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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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Porcelain Repair Kit (Clear) includes 1 (2.5 cc) PorcelETCH™ Clear, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.
COSMEDENT, INC.
661015
In Commercial Distribution

  • D7796610153 ()
661015

  • Dental repair kit, ceramic
Porcelain Repair Kit (Green) includes 1 (2.5 cc) PorcelETCH™ Green, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.
COSMEDENT, INC.
661005
In Commercial Distribution

  • D7796610053 ()
661005

  • Dental repair kit, ceramic
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/bx,
In Commercial Distribution

  • 00810008215890 ()
  • 00810008215883 ()
  • 00810008215906 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 30 Gauge
  • Length: 8 Millimeter
2255

  • Insulin syringe/needle, basic
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 1ml/cc, 31g x 5/16"(8mm), U-100, 10/bg x 10, 100/bx,
In Commercial Distribution

  • 00810008215869 ()
  • 00810008215852 ()
  • 00810008215876 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 31 Gauge
  • Length: 8 Millimeter
2254

  • Insulin syringe/needle, basic
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 0.5ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/b
In Commercial Distribution

  • 00810008215838 ()
  • 00810008215821 ()
  • 00810008217009 ()

  • Total Volume: 0.5 Milliliter
  • Needle Gauge: 30 Gauge
  • Length: 8 Millimeter
2248

  • Insulin syringe/needle, basic
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 0.3ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/b
In Commercial Distribution

  • 00810008215807 ()
  • 00810008215791 ()
  • 00810008216996 ()

  • Total Volume: 0.3 Milliliter
  • Needle Gauge: 30 Gauge
  • Length: 8 Millimeter
2242

  • Insulin syringe/needle, basic
BREAST 7 BIOPSY PACK, 1.5T contains - 3 Grid Immobilization Plate LBS M-L; 3 Pillar Immobilization Plate LBS M-L; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assembly; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 Grid Immobilization Plate LBS; 3 Pillar Immobilization Plate LBS C-C; 2 Fiducial Marker Sleeve Assembly; MRI Needle Sleeve 16G; Fiducial Marker Grid Block Assembly; 2 Needle Block Holder.
Philips Medical Systems Nederland B.V.
989603110736
In Commercial Distribution

  • 00884838118782 ()


  • Needle guide, single-use
  • Needle guide, reusable
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901350
In Commercial Distribution

  • 00841549107351 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901349
In Commercial Distribution

  • 00841549107344 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901348
In Commercial Distribution

  • 00841549107337 ()


  • Screw endosteal dental implant, two-piece
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