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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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Collage Osteoconductive Scaffold - Putty - 10381780112051

The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages. The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate. The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Integra Lifesciences Corporation
710010
Not in Commercial Distribution

  • 10381780112051 ()

  • 10 cc
710010

  • Bone matrix implant, composite

Access Port RapidPort EZ Kit - 10811955020251

RAPIDPORT EZ Access Port Kit 14CC
Apollo Endosurgery, Inc.
B-2306
Not in Commercial Distribution

  • 10811955020251 ()

  • 14 cc
B-2306

  • Gastric band access port kit

Access Port RapidPort EZ Kit - 10811955020244

RAPIDPORT EZ Access Port Kit 10CC
Apollo Endosurgery, Inc.
B-2304
Not in Commercial Distribution

  • 10811955020244 ()

  • 10 cc
B-2304

  • Gastric band access port kit

LAP-BAND System Access Port I Kit - 10811955020138

Access Port I Kit 0-14CC
Apollo Endosurgery, Inc.
B-2107
Not in Commercial Distribution

  • 10811955020138 ()

  • 0-14 cc
B-2107

  • Gastric band access port kit

LAP-BAND System Access Port II Kit - 10811955020121

Access Port II Kit 0-14CC
Apollo Endosurgery, Inc.
B-2106
Not in Commercial Distribution

  • 10811955020121 ()

  • 0-14 cc
B-2106

  • Gastric band access port kit

LAP-BAND System Access Port I Kit - 10811955020107

Access Port I Kit 0-10CC
Apollo Endosurgery, Inc.
B-2104
Not in Commercial Distribution

  • 10811955020107 ()

  • 0-10 cc
B-2104

  • Gastric band access port kit

ZZ BASE NB-A-ICSC WP (Impression coping Screw) - D800BSFE2404

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2404
In Commercial Distribution

  • D800BSFE2404 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-ICSC CC 3.0 (Impression coping Screw) - D800BSFE2403

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2403
In Commercial Distribution

  • D800BSFE2403 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-ICSC RP (Impression coping Screw) - D800BSFE2402

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2402
In Commercial Distribution

  • D800BSFE2402 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-ICSC NP (Impression coping Screw) - D800BSFE2401

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2401
In Commercial Distribution

  • D800BSFE2401 ()


  • Dental implant suprastructure, temporary, preformed, reusable
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