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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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Integra® - 10381780264088

GLASS L.O.R. SYRINGE 5CC (LUER SLIP
INTEGRA PAIN MANAGEMENT
PISGLS5
Not in Commercial Distribution

  • 30381780264082 ()
  • 10381780264088 ()
  • M610PISGLS51 ()

  • 5 CC


  • General surgical procedure kit, medicated

Integra® - 10381780264071

GLASS L.O.R. SYRINGE 5CC (LUER LOCK)
INTEGRA PAIN MANAGEMENT
PISGLL5
Not in Commercial Distribution

  • 30381780264075 ()
  • 10381780264071 ()
  • M610PISGLL51 ()

  • 5 CC


  • General surgical procedure kit, medicated

Integra® - 10381780264064

10CC GLASS L.O.R. (LUER LOCK)
INTEGRA PAIN MANAGEMENT
PISGLL10
Not in Commercial Distribution

  • 30381780264068 ()
  • 10381780264064 ()
  • M610PISGLL101 ()

  • 10 CC


  • General surgical procedure kit, medicated

Collage Osteoconductive Scaffold - Putty - 10381780114352

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
710015
Not in Commercial Distribution

  • M2697100151 ()
  • 10381780114352 ()

  • 15 cc
710015

  • Bone matrix implant, composite

Collage Osteoconductive Scaffold - Putty - 10381780114345

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

  • M2697100101 ()
  • 10381780114345 ()

  • 10 cc
710010

  • Bone matrix implant, composite

Collage Osteoconductive Scaffold - Putty - 10381780114338

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
710005
Not in Commercial Distribution

  • M2697100051 ()
  • 10381780114338 ()

  • 5 cc
710005

  • Bone matrix implant, composite

Integra OS™ - 10381780112082

Integra OS™ Osteoconductive Scaffold - 5cc Putty
Integra Lifesciences Corporation
IOS10155
Not in Commercial Distribution

  • M269IOS101551 ()
  • 10381780112082 ()

  • 5 cc
IOS10155

  • Bone matrix implant, composite

Integra OS™ - 10381780112075

Integra OS™ Osteoconductive Scaffold - 2.5cc Putty
Integra Lifesciences Corporation
IOS10125
Not in Commercial Distribution

  • M269IOS101251 ()
  • 10381780112075 ()

  • 2.5 cc
IOS10125

  • Bone matrix implant, composite

Collage Osteoconductive Scaffold - Putty - 10381780112068

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
710015
Not in Commercial Distribution

  • 10381780112068 ()

  • 15 cc
710015

  • Bone matrix implant, composite

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

Collage Osteoconductive Scaffold - Putty - 10381780112044

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
710005
Not in Commercial Distribution

  • 10381780112044 ()

  • 5 cc
710005

  • Bone matrix implant, composite

InterGro DBM Plus - 00888480585251

DBM in a Lipid Carrier with Porous Calcium Granules
Biomet Orthopedics, LLC
DBMW10
In Commercial Distribution

  • 00888480585251 ()

  • 10 cc
DBMW10

  • Bone matrix implant, human-derived

InterGro DBM Plus - 00888480585220

DBM in a Lipid Carrier with Porous Calcium Granules
Biomet Orthopedics, LLC
DBMW05
In Commercial Distribution

  • 00888480585220 ()

  • 5 cc
DBMW05

  • Bone matrix implant, human-derived

InterGro DBM Plus - 00888480585213

DBM in a Lipid Carrier with Porous Calcium Granules
Biomet Orthopedics, LLC
DBMW02
In Commercial Distribution

  • 00888480585213 ()

  • 2 cc
DBMW02

  • Bone matrix implant, human-derived

InterGro DBM Putty - 00888480585169

Demineralized Bone Matrix (DBM) in a Lipid Carrier
Biomet Orthopedics, LLC
DBM010
In Commercial Distribution

  • 00888480585169 ()

  • 10 cc
DBM010

  • Bone matrix implant, human-derived

InterGro DBM Paste - 00888480585145

Demineralized Bone Matrix (DBM) in a Lipid Carrier
Biomet Orthopedics, LLC
DBM005
In Commercial Distribution

  • 00888480585145 ()

  • 5 cc
DBM005

  • Bone matrix implant, human-derived

InterGro DBM Paste - 00888480585138

Demineralized Bone Matrix (DBM) in a Lipid Carrier
Biomet Orthopedics, LLC
DBM002
In Commercial Distribution

  • 00888480585138 ()

  • 2 cc
DBM002

  • Bone matrix implant, human-derived

InterGro DBM Paste - 00888480585121

Demineralized Bone Matrix (DBM) in a Lipid Carrier
Biomet Orthopedics, LLC
DBM001
In Commercial Distribution

  • 00888480585121 ()

  • 1 cc
DBM001

  • Bone matrix implant, human-derived

Continuum® Trilogy® Allofit® - 00889024147485

No Description
Zimmer, Inc.
00-8732-004-22
In Commercial Distribution

  • 00889024147485 ()

  • Lumen/Inner Diameter: 22 Millimeter
  • Size CC
00-8732-004-22

  • Acetabulum prosthesis trial, prefabricated, reusable

Continuum® Trilogy® - 00889024152502

No Description
Zimmer, Inc.
00-8791-040-00
In Commercial Distribution

  • 00889024152502 ()

  • Outer Diameter: 40 Millimeter
  • Size CC
00-8791-040-00

  • Acetabulum prosthesis trial, prefabricated, reusable

Continuum® Trabecular Metal™ - 00889024151215

No Description
Zimmer, Inc.
00-8757-040-02
In Commercial Distribution

  • 00889024151215 ()

  • Outer Diameter: 40 Millimeter
  • Size CC
00-8757-040-02

  • Acetabular shell

Continuum® Trabecular Metal™ - 00889024151208

No Description
Zimmer, Inc.
00-8757-040-00
In Commercial Distribution

  • 00889024151208 ()

  • Size CC
  • Outer Diameter: 40 Millimeter
00-8757-040-00

  • Acetabular shell

Continuum® Trilogy® Allofit® Longevity® - 00889024150355

No Description
Zimmer, Inc.
00-8754-004-28
In Commercial Distribution

  • 00889024150355 ()

  • Size CC
  • Lumen/Inner Diameter: 28 Millimeter
00-8754-004-28

  • Non-constrained polyethylene acetabular liner

Continuum® Trilogy® Allofit® Longevity® - 00889024149601

No Description
Zimmer, Inc.
00-8752-004-22
In Commercial Distribution

  • 00889024149601 ()

  • Lumen/Inner Diameter: 22 Millimeter
  • Size CC
00-8752-004-22

  • Non-constrained polyethylene acetabular liner

Continuum® Trilogy® - 00889024153530

No Description
Zimmer, Inc.
00-8832-004-22
In Commercial Distribution

  • 00889024153530 ()

  • Lumen/Inner Diameter: 22 Millimeter
  • Size CC
00-8832-004-22

  • Acetabulum prosthesis trial, prefabricated, reusable

Continuum® Trilogy® Allofit® Vivacit-E® - 00889024364486

No Description
Zimmer, Inc.
00-8852-004-22
In Commercial Distribution

  • 00889024364486 ()

  • Lumen/Inner Diameter: 22 Millimeter
  • Size CC
00-8852-004-22

  • Non-constrained polyethylene acetabular liner

Trilogy® - 00889024364400

No Description
Zimmer, Inc.
00-8753-040-02
In Commercial Distribution

  • 00889024364400 ()

  • Size CC
  • Outer Diameter: 40 Millimeter
00-8753-040-02

  • Acetabular shell

BiomaX - 00810076560694

BiomaX Bone Graft Putty Plus Chips, 10cc
Surgalign Spine Technologies, Inc.
BMX-0110
In Commercial Distribution

  • 00810076560694 ()

  • 10 cc


  • Bone matrix implant, human-derived

BiomaX - 00810076560670

BiomaX Bone Graft Putty Plus Chips, 2.5cc
Surgalign Spine Technologies, Inc.
BMX-0102
In Commercial Distribution

  • 00810076560670 ()

  • 2.5 cc


  • Bone matrix implant, human-derived

BiomaX - 00810076560007

BiomaX Bone Graft Putty, 1cc
Surgalign Spine Technologies, Inc.
BMX-0001
In Commercial Distribution

  • 00810076560007 ()

  • 1 cc


  • Bone matrix implant, human-derived

BiomaX - 00810076560687

BiomaX Bone Graft Putty Plus Chips, 5cc
Surgalign Spine Technologies, Inc.
BMX-0105
In Commercial Distribution

  • 00810076560687 ()

  • 5 cc


  • Bone matrix implant, human-derived

BiomaX - 00810076560663

BiomaX Bone Graft Putty Plus Chips, 1cc
Surgalign Spine Technologies, Inc.
BMX-0101
In Commercial Distribution

  • 00810076560663 ()

  • 1 cc


  • Bone matrix implant, human-derived

BiomaX - 00810076560656

BiomaX Bone Graft Putty, 10cc
Surgalign Spine Technologies, Inc.
BMX-0010
In Commercial Distribution

  • 00810076560656 ()

  • 10 cc


  • Bone matrix implant, human-derived

BiomaX - 00810076560649

BiomaX Bone Graft Putty, 5cc
Surgalign Spine Technologies, Inc.
BMX-0005
In Commercial Distribution

  • 00810076560649 ()

  • 5 cc


  • Bone matrix implant, human-derived

BiomaX - 00810076560380

BiomaX Bone Graft Putty, 2.5cc
Surgalign Spine Technologies, Inc.
BMX-0002
In Commercial Distribution

  • 00810076560380 ()

  • 2.5 cc


  • Bone matrix implant, human-derived

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

HU-FRIEDY - 10889950020286

CC DE #2 Nabers Probe 3-6-9-12,#8 hdl
HU-FRIEDY MFG. CO., LLC
PQ2N8
In Commercial Distribution

  • 10889950020286 ()
PQ2N8

  • Dental surgical probe, reusable
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