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LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

The LED Facial Mask is an over-the-counter, facemask-shaped design light emitting diode (LED) device that emits light energy in the red, blue, and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The device consists of a mask body unit, controller, and AC adapter. The mask body unit contains light emitting diodes (LEDs) that emit visible red light (650nm+/-5nm), amber light (605nm+/-5nm), or blue light (465nm+/-5nm) to help reduce the appearance of wrinkles or mild to moderate acne. A controller is connected to the mask body unit to control the device, such as turn on/off the device, switch LED color output. An AC adapter is used to power the device. To use the device, user should place the mask body unit over the face and use the controller to operate. The device will automatically turn off after each treatment. The LED Facial Mask includes MZ-01, NEWKEY-01, and SP-FM-01 models. Their intended use, performance, structure design, and operation are identical, with the difference being the product appearance, but these differences do not affect or change the intended use of the device.

The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: • Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. • Ethylene Oxide (EO) with a concentration of 800 mg/L at 55° C (131° F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃). The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from prink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization. The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).

The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is: Steam: 4 minutes at 132°C (270°F); 20 minutes dry time. Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20 ℃. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 24 months post sterilization. The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

Surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.

The Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene. The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The ear straps/ear loops are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Poly Ethylen. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below: Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below: - To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions. Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: - - Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion . - and tumor resections . Long Nail Indications: - - . Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. Elastic Nails: The Elastic Nail is indicated for fixation of diaphyseal fractures of the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures and lower extremity fractures in paediatic or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate. K-Wires: K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system All implants are for single use only.

GPC Intraheal Intramedullary Nailing System are manufactured in various shapes and sizes. The intramedullary nails are fixed with corresponding sizes of locking bolts and end caps. GPC Intraheal Intramedullary Nailing System are manufactured using stainless steel or titanium materials for surgical implant applications. The different sizes and model numbers of GPC Intraheal Intramedullary Nailing System are based on the site of application such as fixation or reconstruction of the bones. These intramedullary nails are available in different diameters and lengths to suit the patient anatomy and size of the bones. GPC Intraheal Intramedullary Nailing System are typically divided into following three categories: - 1. Femoral Nails and corresponding locking bolts and end cap for fixation - 2. Elastic Nails and corresponding end caps for fixation - 3. K wire for fixation The specific names of the GPC Intraheal Intramedullary Nails are as given below: Multi Angle Femoral Nail Proximal Hip Stabilizing Nail 3 (Also called as PHN3) Elastic Nail K.Wire

GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The system is indicated for use in adult patients only. All implants are for single use only.

GPC Variable Angle Locking Two Column Volar Distal Radius Plates are machined metal plates designed for fixation of various fracture modes of the distal portion of the Variable Angle Locking Two Column Volar Distal Radius Plates allow fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The variable angle locking mechanism improves the plate-screw construct stability. GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured using titanium material for surgical implant applications. Following are the types of the GPC Variable Angle Locking Two Column Volar Distal Radius Plates: - Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 22 mm, 6 Head Holes (with option of Left and Right Variants) - Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 25.5 mm, 7 Head Holes (with option of left and right variants) - Variable Angle Locking Two Column Volar Distal Radius Plate- Narrow, Width 19.5 mm, 6 Head Holes (with option of left and right variants) Corresponding Screws for fixation: - Variable Angle Locking Screw 2.4 mm, Star drive Lengths: 6mm to 30mm in 2mm increments - FixLOCK Self-Tapping Screw 2.4 mm, Star drive Length 6mm to 30mm in 2mm increments - Self-Tapping Cortex Screw 2.7 mm, Star drive Length: 12mm to 24mm These implants are supplied non-sterile, the products have to be sterilized prior to use.

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D or roflufocon E-with the following properties: Refractive Index, Light Transmission (clear), Light Transmission (tinted), Wetting Angle (Dynamic contact receding angle), Specific Gravity, Oxygen Permeability (Dk) ISO/FATT Method, Visitint lenses contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D. The lenses are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Secondary Curves, Peripheral Curves, Multifocal Power.

The Spiral Shape Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Spiral Shape Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16 (no 6.0 diameter in 16). Both straight and angled abutments are available. The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients: 1. Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies) 2. Spondylolisthesis 3. Trauma (Fracture or Dislocation) 4. Spinal Stenosis 5. Scoliosis, Kyphosis and/or lordosis 6. Pseudoarthrosis 7. Failed Previous Fusion The system is indicated for use in adult patients only. All implants are for single use only.

The Monoaxial & Polyaxial screw consists of a body, bushing, and ball head screw. Inner Screw, rods and transverse connectors assemblies complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post or monoaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned. The Screws, Rods &Transverse Connectors are fabricated from Titanium. The system contains several models based on the size of the device and application site such as fixation/reconstruction spine. - Single Lock Monoaxial Screw - Single Lock Polyaxial Screw - Transverse connector - Rod The diameter of these screw varies from 4mm to 7mm with length 25mm to 50mm. The corresponding connector are small & large in size. The diameter of Rod is 5.5mm with length 75mm to 150mm These implants are supplied non-sterile; the products have to be sterilized prior to use.

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). The system is indicated for use in adult patients only. All implants are for single use only.

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws. The plates and screws are fabricated from Stainless Steel and Titanium. GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T-Plates, Anatomical Plates and Clavicle Hook Plates. These all are mainly divided into - Large Fragment Plates - . Small Fragment Plates - Mini Fragment Plates ● The number of the holes varies from 2 to 22. The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm. The non locking screws 3.5mm and 4.5mm were cleared previously in 510k number K092493 These implants are supplied non-sterile, the products have to be sterilized prior to use.

1. Indication for Use: Multi Angle Tibial Nail is intended to stabilize fracture of the proximal & distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions & nonunions. 2. Indications for Use: Ga-mma Nail is indicated for use in stabilizing various types of intertrochanteric fractures of proximal femur.

The GPC Intramedullary Nailing Systems include intramedullary nails and corresponding screws/end caps/locking bolts for fastening these intramedullary nails to the fractured bones.