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GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

GPS Advanced is a sterile, single use dispenser for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The dispenser has a ratcheted plunger that advances with each squeeze of its handle. The 5 cc GPS Advanced Cannula ("GPS Advanced Cannula") is available individually packaged and can be attached to the dispenser. GPS Advanced is provided sterile via irradiation and GPS Advanced Cannula is provided sterile via ethylene oxide. The GPS Advanced Cannula is provided empty and needs to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

GO-PEN® is a reusable insulin pen intended for the self-injection of NovoLog® (U-100, insulin aspart for injection) available in 10 ml vials.

GO-PEN® is an assembly of a durable pen-shaped dosing unit with a special disposable sterile reservoir that fits into the dosing unit. The GO-PEN® device can only be used with NovoLog® U-100 insulin aspart for injection. The user is intended to fill up the disposable reservoir with 1.3 mL of insulin from a 10 ml vial and mount it on the dosing unit. The GO-PEN® device allows the user to set the desired dose from 1 to 60 Units in 1 Unit increments using the dial feature. Once the GO-PEN® disposable reservoir is filled, it can be used over a period of up to 3 days at room temperature (max. 30°C/86°F) for multiple injections of precise doses of insulin. When the reservoir is empty or the time has been exceeded, the reservoir must be discarded, and a new sterile reservoir is used for the next filling. GO-PEN® is used with standard single-use hypodermic needles with a luer lock which are supplied separately by the user.

The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.

The GraftGun Universal Graft Delivery System (GDS®) consists of a sterile, single-use, disposable device, and non-sterile reusable Adapter Tips intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The GraftGun Universal Graft Delivery System (GDS®) includes the GraftGun Dispensing Unit, Loading Device, Graft Tubes, and Adapter Tips.

The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.

The Insulin Syringes are 0.3 mL, 0.5 mL, or 1.0 mL synnges designed for subcutaneous injection of a desired dose of insulin. The Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (25G, 26G, 27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm). The Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.

Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw from body. Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw from body. The filter operates when injecting the human body to remove foreign substances from the drug solutions.

Single use Syringe with or without Needle consist of Syringe, Cap, Needle and Hub and Blister paper. Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization, and the syringes of Luer Slip and Luer Lock. These devices are injecting the medicine with syringes. Biocompatibility testing and performance testing has been completed to support the substantial equivalence of the device.

The syringe without needle is used to inject fluids into, or withdraw fluids from, the body.

The Slip Tip and Eccentric Tip Syringe without Needle is a sterile, single-use, standard 3 piece piston. The device is packed individually and EO sterilized with 10-6 SAL. The proposed device includes different specifications: 1ml Slip Tip Syringe without Needle 3ml Slip Tip Syringe without Needle 5ml Slip Tip Syringe without Needle 10ml Slip Tip Syringe without Needle 20ml Slip Tip Syringe without Needle 30ml Slip Tip Syringe without Needle 60ml Slip Tip Syringe without Needle 10ml Eccentric Tip Syringe without Needle 20ml Eccentric Tip Syringe without Needle 60ml Eccentric Tip Syringe without Needle

The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from. the body. The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.

The Luer Lock Syringe with Exchangeable Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. The Luer Lock with Safety Needle is a syringe and needle combination with the safety needle. It contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Safety needle can be pre-attached or aside the syringe. The Luer Lock Syringe with Blunt Fill Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. It is used for aspiration from multi-dose medicine vials. The proposed devices are offered in various gauge sizes and length. The proposed devices are available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The device is for medical professionals use only and for prescription use only. - Luer Lock Syringe with Safety Needle (Syringe range: 1ml, 3ml, 5ml,10ml; Needle range: 20G, 21G, 23G, 25G; Needle length from 5/8" to 1 1/2"). The Safety needle can be pre-attached or aside the syringe. - Luer Lock Syringe with Exchangeable Needle (Syringe range: 3ml, 5ml, 10ml, Needle range: 20G, 21G, 22G, 23G, 25G; Needle length from 5/8" to 1 1/2"). - Luer Lock Syringe with Blunt Fill Needle (Syringe range: 3ml, 5ml, 10ml, Needle: 18G, Needle length:1 1/2").

Tamper Evident Caps (Sterile) are indicated for use as a sterile tamper evident cap for IV syringes.

The International Medical Industries, Inc. Tamper Evident Cap consists of a polystyrene outer sleeve and bottom cover and a polypropylene tip cap held in place by a breakaway ring integrated into the sleeve. Evidence of access to the Luer lock cap is achieved by physically breaking the connection and removing the polystyrene outer sleeve exposing the Luer lock cap. Removal of the Luer Lock Cap is restricted by the presence of the sleeve. The restrictive sleeve and cap are available in multiple colors (cosmetic purposes only) in individual blister packs and trays of 10. The Luer Lock Caps are provided sterile to the end user. The sterilization method used is Ethylene Oxide.