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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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ProxiCor for Cardiac Tissue Repair - 00859389005041

ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
Elutia Med LLC
CMCV-064-401
In Commercial Distribution

  • 10859389005048 ()
  • 00859389005041 ()

  • Width: 7 Centimeter
  • Height: 10 Centimeter


  • Cardiovascular patch, animal-derived

CanGaroo Envelope - 00859389005034

The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Elutia Med LLC
CMCV-009-MED
In Commercial Distribution

  • 10859389005031 ()
  • 00859389005034 ()

  • Medium


  • Cardiovascular patch, animal-derived

CanGaroo Envelope - 00859389005027

The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Elutia Med LLC
CMCV-009-SML
In Commercial Distribution

  • 10859389005024 ()
  • 00859389005027 ()

  • Small


  • Cardiovascular patch, animal-derived

ProxiCor for Pericardial Closure - 00859389005010

ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Elutia Med LLC
CMCV-060-402
In Commercial Distribution

  • 10859389005017 ()
  • 00859389005010 ()

  • Width: 7.0 Centimeter
  • Height: 15.0 Centimeter


  • Cardiovascular patch, animal-derived

ProxiCor for Pericardial Closure - 00859389005003

ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Elutia Med LLC
CMCV-059-401
In Commercial Distribution

  • 00859389005003 ()
  • 10859389005000 ()

  • Height: 10 Centimeter
  • Width: 7 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160555

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Elutia Med LLC
440579
In Commercial Distribution

  • 04035479160647 ()
  • 04035479160555 ()

  • SubQ


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160548

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Elutia Med LLC
440578
In Commercial Distribution

  • 04035479160548 ()
  • 04035479160654 ()

  • Width: 9.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160531

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Elutia Med LLC
440577
In Commercial Distribution

  • 04035479160531 ()
  • 04035479160616 ()

  • Width: 8.0 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160524

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Elutia Med LLC
440576
In Commercial Distribution

  • 04035479160524 ()
  • 04035479160623 ()

  • Width: 6.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160517

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Elutia Med LLC
440575
In Commercial Distribution

  • 04035479160517 ()
  • 04035479160630 ()


  • Cardiovascular patch, animal-derived

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

Medtronic Reusable Instruments - 00763000056223

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

  • 00763000056223 ()


  • Bone graft packing block

Global Spinal Fixation System™ - 08800015946414

No Description
Innosys Co., Ltd.
SG0019
In Commercial Distribution

  • 08800015946414 ()


  • Bone graft packing block

Velofix™ PEEK Lumbar Cage - 08800015954730

No Description
Innosys Co., Ltd.
PL0450
In Commercial Distribution

  • 08800015954730 ()


  • Bone graft packing block

VELOFIX™ PEEK CERVICAL CAGE - 08800015953986

No Description
Innosys Co., Ltd.
PE1020
In Commercial Distribution

  • 08800015953986 ()


  • 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

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

JULIET INSTRUMENTATION - 07640139342416

Compactor
SpineArt SA
DYN-IP 00 02-N
In Commercial Distribution

  • 07640139342416 ()
DYN-IP 00 02-N

  • Bone graft packing block

TRYPTIK CC INSTRUMENTATION - 07640151081881

Compactor
SpineArt SA
TRY-IN 01 00-N
In Commercial Distribution

  • 07640151081881 ()
TRY-IN 01 00-N

  • Bone graft packing block

ROMEO 2 PAD INSTRUMENTATION - 07640139349309

Compactor
SpineArt SA
PAD-IN 05 00-N
In Commercial Distribution

  • 07640139349309 ()
PAD-IN 05 00-N

  • Bone graft packing block

ROMEO 2 PAD INSTRUMENTATION - 07640139349293

Compaction Base
SpineArt SA
PAD-IN 04 00-N
In Commercial Distribution

  • 07640139349293 ()
PAD-IN 04 00-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640151087098

COMPACTION BASE (JULIET LL-Instruments)
SpineArt SA
JUL-IN 01 00-N
In Commercial Distribution

  • 07640151087098 ()
JUL-IN 01 00-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640151087050

COMPACTOR
SpineArt SA
JUL-IN 14 00-N
In Commercial Distribution

  • 07640151087050 ()
JUL-IN 14 00-N

  • Bone graft packing block

SCARLET AC-T INSTRUMENTATION - 07640151086435

Compaction base
SpineArt SA
SCA-IC 04 00-N
In Commercial Distribution

  • 07640151086435 ()
SCA-IC 04 00-N

  • Bone graft packing block

icotec Lumbar Cage, Implant Holder for Tamping - 07640164841830

icotec Lumbar Cage, Implant Holder for Tamping
icotec AG
38-036
In Commercial Distribution

  • 07640164841830 ()
38-036

  • 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

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

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 - 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

Velofix™ TLIF Cage - 08800015995474

No Description
Innosys Co., Ltd.
TL0520
In Commercial Distribution

  • 08800015995474 ()


  • 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

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

n/a - 00763000371777

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

  • 00763000371777 ()


  • 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
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