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510(k) Data Aggregation
K Number
K101653Device Name
MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
Manufacturer
MILTEX, INC.
Date Cleared
2010-08-02
(52 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Miltex Sterilization Cassettes (Miltex®, Thompson™) are general dental/surgical instrument cassettes indicated to hold instruments and accessories in place during storage and the sterilization cycle. Suitable for Gravity Steam and Pre-Vacuum Steam, the cassettes are intended to be used in conjunction with sterilization wrap in order to maintain sterility.
Device Description
Miltex® Thompson™ Cassettes are sterilization cassettes made of surgical-grade passivated stainless steel to provide protection, storage and organization for all types of instruments. Miltex® Thompson™ Cassettes may be used in dental, surgical or veterinary procedures. Cassettes are available in a variety of configurations and are designed to fit standard autoclaves.
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K Number
K092855Device Name
MILTEX MEMBRANE TACK KIT
Manufacturer
MILTEX, INC.
Date Cleared
2009-12-29
(104 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Miltex® Membrane Tack Kit is intended to fixate or stabilize guided tissue regeneration membranes to bone at the surgical site.
Device Description
The Miltex® Membrane Tack Kit consists of non-sterile, single use titanium alloy tacks available in 3 mm or 5 mm lengths. Membrane Tacks are used in conjunction with the following accessories and reusable stainless steel instruments for implantation: Tack Membrane Probe, Tack Applicator, Perforation Raspatory, Kirsch Sinus 7 Double-ended Spoon and Plugger, Sinus Elevator, Mixing Cup with Plastic Lid, Tack Storage Box for 15 Tacks and Tack Wash Tray with Lid.
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K Number
K083796Device Name
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
Manufacturer
MILTEX, INC.
Date Cleared
2009-03-09
(77 days)
Product Code
EJI
Regulation Number
872.6770Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Device Description
Miltex® Dental Aspirating Syringes include Standard Aspirating Syringes, Petite Aspirating Syringes, Self-Aspirating Syringe, Lightweight Self-Aspirating Syringe, Articulating Barrel Syringe and GripRite™ Standard and Petite Aspirating Syringes. All syringes are made of chrome-plated brass and stainless steel; Lightweight Self-Aspirating Syringe has aluminum handle. Syringes are reusable, sterilizable and packaged non-sterile.
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K Number
K072563Device Name
MILTEX RIGID CONTAINER SYSTEMS
Manufacturer
MILTEX, INC.
Date Cleared
2008-02-12
(154 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to 200-mm in length were validated. The container is intended for use with non-porous materials such as stainless steel surgical instruments.
For effective sterilization and drying, the weight of the single container, basket and basket contents should not exceed the following: 16 lbs for the one-half size container, 20 Ibs for the three-quarter size container, and 25 Ibs for the full size container.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility for a maximum of 60 days as long as the integrity of the container has not been compromised.
Containers should not be stacked when used within gravity steam sterilizers.
Device Description
The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:
- Container bottoms (perforated versions) .
- . Container baskets,
- . Container lids (perforated only)
The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.
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K Number
K061033Device Name
MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
Manufacturer
MILTEX, INC.
Date Cleared
2006-12-12
(242 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel surgical instruments.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.
Containers should not be stacked when used within cthylene oxide sterilizers
Device Description
The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:
- Container bottoms (both perforated and non-perforated versions)
- Container baskets,
- Container lids (perforated only), and .
- u Container color-coding "labels."
The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.
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K Number
K052018Device Name
MILTEX LIGATING CLIP
Manufacturer
MILTEX, INC.
Date Cleared
2005-11-04
(101 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.
Device Description
The Miltex Ligating Clip is constructed exclusively of CP Grade 1 titanium wire having a heart-shaped cross-section. The clip is chevron-shaped. The inside (tissue-engaging) surfaccs of the clip legs have a longitudinal groove intersected by a number of angled transverse grooves. The longitudinal grooves do not extend fully to the distal ends of the legs, but leave distal flat surfaces at the ends of the legs. When the clip is closed, tissue will fill in the grooves, providing secure retention on the vessel. This feature also improves the occluding functions of the clip. The distal flat ends of the legs provide surfaces that will contact each other initially as the clip is closed. The contact of the distal flat surfaces will cause the legs to straighten in alignment with cach other, thereby minimizing the possibility of scissoring. Clips are available in 4 sizes: small, medium, medium-large, and large. The clips are packaged six per disposable cartridge holder. The clips and cartridge holder are supplied sterile. Cartridge holders are color-coded using the industry standard color-coding system.
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K Number
K050570Device Name
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
Manufacturer
MILTEX, INC.
Date Cleared
2005-07-25
(143 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers. The containers have been validated for sterilization of instruments with lumens up to 3 mm I.D. by 400 mm length, for the Full (large) size container and up to 3mm I.D. by 200mm length for the ½ (small) and ¼ (medium) size containers. Sterilized devices may be stored and transported within the container.
Device Description
The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:
- Container bottoms (both perforated and non-perforated versions)
- Container baskets,
- Container lids (perforated only), and
- Container color-coding "labels."
The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.
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K Number
K043013Device Name
MILTEX LAPAROSCOPIC INSTRUMENTS
Manufacturer
MILTEX, INC.
Date Cleared
2005-03-04
(122 days)
Product Code
HET
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
Device Description
These devices represent a family of monopolar laparoscopic instruments that consist of:
- Stainless Steel Handle (non-ratcheted)
- Stainless Steel Pull Rod attached to a stainless steel jaw
- Insulation material composed of PPSU (PolyPhenylSulfone)
Various configurations of the jaw (graspers, cutters, dissectors, and punches) exist to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.
These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag.
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K Number
K013888Device Name
FIXATION (STEINMANN) PINS
Manufacturer
MILTEX, INC.
Date Cleared
2002-05-01
(159 days)
Product Code
HTY, IDW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MILTEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. It is the intention of Miltex Inc. to introduce into the marketplace a line of Fixation/Steinmann Pins both Smooth and Threaded.
2. The material is 316LVM, Stainless Steel and the Pins are to be utilized for internal fixation of bone fractures.
3. The Pins are used specifically for fractures of the proximal or distal end of long bones such as intracapsular intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur.
4. The device(s) may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Device Description
Steinmann and Fixation Pins, Smooth and Threaded. The material is 316LVM, Stainless Steel.
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