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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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CardioCel 3D - 09348992000358

CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture.
ADMEDUS REGEN PTY LTD
UC0406A60
In Commercial Distribution

  • 09348992000358 ()

  • Width: 4 Centimeter
  • Length: 6 Centimeter
  • Angle: 60 degree
C0406A60

  • Cardiovascular patch, animal-derived

CardioCel 3D - 09348992000327

CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture.
ADMEDUS REGEN PTY LTD
UC0307A90
In Commercial Distribution

  • 09348992000327 ()

  • Width: 3 Centimeter
  • Length: 7 Centimeter
  • Angle: 90 degree
C0307A90

  • Cardiovascular patch, animal-derived

CardioCel 3D - 09348992000280

No Description
ADMEDUS REGEN PTY LTD
UC0406A
In Commercial Distribution

  • 09348992000280 ()

  • Width: 4 Centimeter
  • Length: 6 Centimeter
  • Angle: 60 degree
C0406A

  • Cardiovascular patch, animal-derived

VascuCel - 09348992000266

The VascuCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UV0880
In Commercial Distribution

  • 09348992000266 ()

  • Width: 8 Centimeter
  • Length: 0.8 Centimeter
V0880

  • Cardiovascular patch, animal-derived

CardioCel Agile - 09348992000198

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0508A
In Commercial Distribution

  • 09348992000198 ()

  • Length: 5 Centimeter
  • Width: 8 Centimeter
C0508

  • Cardiovascular patch, animal-derived

CardioCel Agile - 09348992000181

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0404A
In Commercial Distribution

  • 09348992000181 ()

  • Length: 4 Centimeter
  • Width: 4 Centimeter
C0404

  • Cardiovascular patch, animal-derived

CardioCel Neo - 09348992000150

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen
ADMEDUS REGEN PTY LTD
UC0508N
In Commercial Distribution

  • 09348992000150 ()

  • Width: 8 Centimeter
  • Length: 5 Centimeter
C0508

  • Cardiovascular patch, animal-derived

CardioCel Neo - 09348992000143

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet acellular collagen.
ADMEDUS REGEN PTY LTD
UC0404N
In Commercial Distribution

  • 09348992000143 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter
C0404

  • Cardiovascular patch, animal-derived

CardioCel VSD - 09348992000105

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0202
In Commercial Distribution

  • 09348992000105 ()

  • Width: 2 Centimeter
  • Length: 2 Centimeter
C0202

  • Cardiovascular patch, animal-derived

CardioCel - 09348992000082

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0208
In Commercial Distribution

  • 09348992000082 ()

  • Width: 8 Centimeter
  • Length: 2 Centimeter
C0208

  • Cardiovascular patch, animal-derived

CardioCel - 09348992000037

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, light yellow to beige coloured, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0614
In Commercial Distribution

  • 09348992000037 ()

  • Width: 14 Centimeter
  • Length: 6 Centimeter
C0614

  • Cardiovascular patch, animal-derived

CardioCel - 09348992000020

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, light yellow to beige coloured, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0508
In Commercial Distribution

  • 09348992000020 ()

  • Width: 8 Centimeter
  • Length: 5 Centimeter
C0508

  • Cardiovascular patch, animal-derived

CardioCel - 09348992000013

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, light yellow to beige coloured, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0404
In Commercial Distribution

  • 09348992000013 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter
C0404

  • Cardiovascular patch, animal-derived

CardioCel - 09348992000006

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, light yellow to beige coloured, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UC0202
In Commercial Distribution

  • 09348992000006 ()

  • Width: 2 Centimeter
  • Length: 2 Centimeter
C0202

  • Cardiovascular patch, animal-derived

EluPro Antibiotic-Eluting BioEnvelope - 00859389005348

The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.
AZIYO BIOLOGICS, INC.
CMCV-124-LRG
In Commercial Distribution

  • 00859389005348 ()
  • 10859389005345 ()

  • Large


  • Cardiovascular patch, animal-derived

EluPro Antibiotic-Eluting BioEnvelope - 00859389005331

The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.
AZIYO BIOLOGICS, INC.
CMCV-124-MED
In Commercial Distribution

  • 00859389005331 ()
  • 10859389005338 ()

  • Medium


  • Cardiovascular patch, animal-derived

Unity - 08800039822183

SIJ Bone Graft Packing Instrument
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039822183 ()
SI.IN.0031

  • Bone graft packing block

NA - 08800042415952

Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block

NA - 08800048410296

TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block

NA - 08800048404127

Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block

NA - 08800048402215

Platform - W11 (Dynamic/Varian&EP)
Medyssey Co., Ltd.
NDPF-001
In Commercial Distribution

  • 08800048402215 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223123

Bone Condenser 8/9
BLUE SKY BIO LLC
STPCND89
In Commercial Distribution

  • 00810060223123 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223109

Bone Condenser 6/7
BLUE SKY BIO LLC
STPCND67
In Commercial Distribution

  • 00810060223109 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223093

Bone Condenser 4/5
BLUE SKY BIO LLC
STPCND45
In Commercial Distribution

  • 00810060223093 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223086

Bone Condenser 2/3
BLUE SKY BIO LLC
STPCND23
In Commercial Distribution

  • 00810060223086 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223079

Bone Condenser 10/11
BLUE SKY BIO LLC
STPCND1011
In Commercial Distribution

  • 00810060223079 ()


  • Bone graft packing block

PERLA TL - 07640375236173

CURVED TAMP
SpineArt SA
SPE-US 01 42-N
In Commercial Distribution

  • 07640375236173 ()
SPE-US 01 42-N

  • Bone graft packing block

SCARLET® AC-Ti - 07640332478455

COMPACTION BASE
SpineArt SA
SCA-IC 17 00-N
In Commercial Distribution

  • 07640332478455 ()
SCA-IC 17 00-N

  • Bone graft packing block

PERLA ® TL MIS - 07640450867872

MODULAR SCREW BASE
SpineArt SA
MPF-IN 33 00-N
In Commercial Distribution

  • 07640450867872 ()
MPF-IN 33 00-N

  • Bone graft packing block

TRYPTIK ® TI - 07640450863478

COMPACTION BASE
SpineArt SA
TRY-IN 53 00 -N
In Commercial Distribution

  • 07640450863478 ()
TRY-IN 53 00 -N

  • Bone graft packing block

TRYPTIK ® TI - 07640450863461

COMPACTOR
SpineArt SA
TRY-IN 52 00-N
In Commercial Distribution

  • 07640450863461 ()
TRY-IN 52 00-N

  • Bone graft packing block

JULIET ® INSTRUMENTATION - 07640178983052

ANGULATED IMPACTOR
SpineArt SA
JLL-IN 11 02-N
Not in Commercial Distribution

  • 07640178983052 ()
JLL-IN 11 02-N

  • Bone graft packing block

JULIET ® INSTRUMENTATION - 07640178982819

STRAIGHT IMPACTOR
SpineArt SA
JLL-IN 11 01-N
Not in Commercial Distribution

  • 07640178982819 ()
JLL-IN 11 01-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640178982765

COMPACTION BASE
SpineArt SA
JLL-IN 08 01-N
In Commercial Distribution

  • 07640178982765 ()
JLL-IN 08 01-N

  • Bone graft packing block

JULIET ® INSTRUMENTATION - 07640178981638

COMPACTION BASE
SpineArt SA
JUT-IN 00 01-N
Not in Commercial Distribution

  • 07640178981638 ()
JUT-IN 00 01-N

  • Bone graft packing block

JULIET ® Ti LL Instrumentation - 07640185342989

Base
SpineArt SA
JLL-IN 44 00-N
In Commercial Distribution

  • 07640185342989 ()
JLL-IN 44 00-N

  • Bone graft packing block

SCARLET AL-T INSTRUMENTATION - 07640185340862

COMPACTOR
SpineArt SA
SCA-IN 19 00-N
In Commercial Distribution

  • 07640185340862 ()
SCA-IN 19 00-N

  • Bone graft packing block

SCARLET AL-T INSTRUMENTATION - 07640185340015

COMPACTION BASE
SpineArt SA
SCA-IN 07 00-N
In Commercial Distribution

  • 07640185340015 ()
SCA-IN 07 00-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139342881

Compaction base
SpineArt SA
DYN-IT 00 03-N
In Commercial Distribution

  • 07640139342881 ()
DYN-IT 00 03-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139342423

Compaction base
SpineArt SA
DYN-IP 00 03-N
In Commercial Distribution

  • 07640139342423 ()
DYN-IP 00 03-N

  • Bone graft packing block

Medtronic Reusable Instruments - 00763000056223

STATION EX0717016 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0717016
In Commercial Distribution

  • 00763000056223 ()


  • Bone graft packing block

n/a - 00763000216948

PACKING STATION EX0818003 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0818003
In Commercial Distribution

  • 00763000216948 ()


  • Bone graft packing block

Anteralign Spinal System with Titan nanoLock Surface technology - 00763000194000

BLOCK 4680011 LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
4680011
In Commercial Distribution

  • 00763000194000 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00763000186319

STATION EX0718010 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0718010
In Commercial Distribution

  • 00763000186319 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00763000177669

STATION X0516086 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X0516086
In Commercial Distribution

  • 00763000177669 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00763000177645

STATION X0314002 DUL SIDED GRFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X0314002
In Commercial Distribution

  • 00763000177645 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00763000134679

BLOCK EX0917036 S.S. LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
EX0917036
In Commercial Distribution

  • 00763000134679 ()


  • Bone graft packing block

n/a - 00763000371777

STATION EX0220045 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0220045
In Commercial Distribution

  • 00763000371777 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00763000387068

STATION EX0420049 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0420049
In Commercial Distribution

  • 00763000387068 ()


  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139349941

Compaction base
SpineArt SA
DYN-IP 01 03-N
In Commercial Distribution

  • 07640139349941 ()
DYN-IP 01 03-N

  • Bone graft packing block
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