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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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NEW BLADE for Precision Cataract Clear Cornea Diamond Knife Black Gold Titanium Handle, 2.4mm 90 Degrees Spear Without Sharp Sides, Angled 30 Degrees Dop J-Slot Bayonet Handle Design, Blade Dimensions 2.4mm Wide By 0.20mm Thick By 6mm Long Compared To Rhein Medical
Med Saver, Inc.
307-04AR-NB
In Commercial Distribution

  • 00194613102258 ()


  • Ophthalmic knife, reusable
Procedure Pack, Sterile, Tenodesis
Medshape, Inc.
1500-02-000
In Commercial Distribution

  • M9701500020000 ()


  • Suturing unit, single-use
  • Suture knot pusher, single-use
  • Ligament graft sizer, noninvasive
  • Orthopaedic bone pin, non-bioabsorbable
Introducing the new Stern SNAP Angled Overdenture Implant Abutment System, compatible with all popular implant systems. Its Innovative Two-piece design allows the SNAP Angled to perform True Angle Correction of up 20 degrees on divergent implants, without the need to rely on a hinging attachment. The System features a New Maximum Durability Cap, (available in 1lb, 2lb, and 3lb,) that does not require a housing, making for a low profile of only 2.5mm and requiring less space needed in the denture. The Stern SNAP is an Innovative, Predictable, and Economical solution for stabilizing your patients’ denture.
STERNGOLD DENTAL LLC
904123
In Commercial Distribution

  • 00841549110382 ()


  • Resilient dental precision attachment
This product is the tube kit used in combination with the compatible balloon controller in medical facilities . Do not use this product for any other purpose The product consists of a tube for connection to the endoscope and over-tube and balloon controller, and a filter. This product is supplied non-sterile. Also, The filter is a single patient use item. Prepare a new filter before use.
FUJIFILM CORPORATION
TY-500D
In Commercial Distribution

  • 04547410324280 ()


  • Medical air low pressure hose
The Provox LaryTube Sizer Kit is intended for use by the prescribing specialist to determine the size(s) of LaryTube that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing specialist who has read the LaryTube Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryTubes are intended for the sizing procedure only. After the correct size(s) have been determined, new LaryTube(s) shall be given to the patient for use.
Atos Medical AB
7648
In Commercial Distribution

  • 07331791005329 ()
7648

  • Tracheostomy tube, non-reinforced, non-customized, reusable
The Provox LaryButton Sizer Kit is intended for use by the prescribing clinician to determine the size(s) of LaryButton that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing clinician who has read the LaryButton Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryButtons are intended for the sizing procedure only. After the correct size(s) have been determined a new LaryButton(s) shall be prescribed to the patient for actual use.
Atos Medical AB
7690
In Commercial Distribution

  • 07331791002779 ()
7690

  • Tracheostoma button
"H&H" Wound Gel (Sterile) is a transparent gel dressing with an amorphous structure, suitable for irregularly shaped wounds. The formulation is designed to achieve isotonicity, allowing the gel to cover the wound bed, providing a moist wound healing environment, and promoting the migration of new epidermal cells. Carboxymethyl cellulose, combined with glycerol and hyaluronic acid, not only helps absorb wound exudate and blood but also forms a moist gel protective layer on the wound bed, providing an optimal moist healing environment while reducing the risk of infection by acting as a barrier to foreign materials.
TRONJEN MEDICAL TECHNOLOGY INC.
WG0030
In Commercial Distribution

  • 04719884331402 ()
  • 04719884331426 ()

  • Total Volume: 30 Milliliter
WG0030

  • Wound hydrogel dressing, non-antimicrobial
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-420
Not in Commercial Distribution

  • M8721242003 ()

  • Total Volume: 3.5 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-120
Not in Commercial Distribution

  • M8721212000 ()

  • Total Volume: 4 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-420
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.5 Milliliter


  • Orbital sphere implant
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