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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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Origin NS Stem - 09348215087241

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5032
In Commercial Distribution

  • 09348215087241 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087234

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5031
In Commercial Distribution

  • 09348215087234 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087227

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5022
In Commercial Distribution

  • 09348215087227 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087210

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5021
In Commercial Distribution

  • 09348215087210 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087203

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5012
In Commercial Distribution

  • 09348215087203 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087180

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5002
In Commercial Distribution

  • 09348215087180 ()


  • Coated hip femur prosthesis, modular

Origin DAA Broach - 09348215080426

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3016
In Commercial Distribution

  • 09348215080426 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080419

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3015
In Commercial Distribution

  • 09348215080419 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080402

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3014
In Commercial Distribution

  • 09348215080402 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080396

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3013
In Commercial Distribution

  • 09348215080396 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080389

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3012
In Commercial Distribution

  • 09348215080389 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080372

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3011
In Commercial Distribution

  • 09348215080372 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080365

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3010
In Commercial Distribution

  • 09348215080365 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080358

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3009
In Commercial Distribution

  • 09348215080358 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080341

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3008
In Commercial Distribution

  • 09348215080341 ()


  • Orthopaedic broach

Simplexa™ Influenza A H1N1 (2009) - 20816101025521

No Description
DIASORIN MOLECULAR LLC
MOL2500
In Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

JBAIDS - 00851458005075

JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Duravess - 00690103199048

Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP2X9
In Commercial Distribution

  • 00690103199048 ()

  • 2 CM X 9 CM
DP2X9

  • Cardiovascular patch, animal-derived

Duravess - 00690103199031

Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP1X6
In Commercial Distribution

  • 00690103199031 ()

  • 1 CM X 6 CM
DP1X6

  • Cardiovascular patch, animal-derived

Duravess - 00690103199024

Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP08X8
In Commercial Distribution

  • 00690103199024 ()

  • 0.8 CM X 8 CM
DP08X8

  • Cardiovascular patch, animal-derived

EDWARDS BOVINE PERICARDIAL PATCH - 00690103144178

No Description
Edwards Lifesciences LLC
4700
In Commercial Distribution

  • 00690103144178 ()

  • 10 CENTIMETERS WIDE BY 15 CENTIMETERS LONG. USER WILL TAILOR TO DESIRED SIZE.
4700

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375087

CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-05NS-0506
In Commercial Distribution

  • 00850023375087 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0506

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375070

CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 7 x 15 cm
Helios Cardio Inc.
CMUS-10NS-0715
In Commercial Distribution

  • 00850023375070 ()

  • Width: 15 Centimeter
  • Height: 1.0 Millimeter
  • Length: 7 Centimeter
CMUS-10NS-0715

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375063

CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0812
In Commercial Distribution

  • 00850023375063 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 1.0 Millimeter
CMUS-10NS-0812

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375056

CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 4 x 7 cm
Helios Cardio Inc.
CMUS-05NS-0407
In Commercial Distribution

  • 00850023375056 ()

  • Length: 4 Centimeter
  • Width: 7 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0407

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375049

CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-05NS-0812
In Commercial Distribution

  • 00850023375049 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0812

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375032

CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 10 x 15 cm
Helios Cardio Inc.
CMUS-10NS-1015
In Commercial Distribution

  • 00850023375032 ()

  • Length: 10 Centimeter
  • Width: 15 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-1015

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375025

CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-10NS-0506
In Commercial Distribution

  • 00850023375025 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0506

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375018

CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm
Helios Cardio Inc.
CMUS-10NS-0816
In Commercial Distribution

  • 00850023375018 ()

  • Length: 8 Centimeter
  • Width: 16 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0816

  • Cardiovascular patch, animal-derived

CardiaMend - 00850023375001

CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0612
In Commercial Distribution

  • 00850023375001 ()

  • Length: 6 Centimeter
  • Width: 12 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0612

  • Cardiovascular patch, animal-derived

VasCure for Carotid Repair - 00859389005089

VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing.
AZIYO BIOLOGICS, INC.
CMCV-072-606
In Commercial Distribution

  • 10859389005086 ()
  • 00859389005089 ()

  • Width: 10 Centimeter
  • Height: 2 Centimeter


  • Cardiovascular patch, animal-derived

CanGaroo Envelope - 00859389005072

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.
AZIYO BIOLOGICS, INC.
CMCV-009-XLG
In Commercial Distribution

  • 10859389005079 ()
  • 00859389005072 ()

  • Extra Large


  • Cardiovascular patch, animal-derived

CanGaroo Envelope - 00859389005065

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.
AZIYO BIOLOGICS, INC.
CMCV-009-LRG
In Commercial Distribution

  • 10859389005062 ()
  • 00859389005065 ()

  • Large


  • Cardiovascular patch, animal-derived

ProxiCor for Cardiac Tissue Repair - 00859389005058

ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
AZIYO BIOLOGICS, INC.
CMCV-067-404
In Commercial Distribution

  • 10859389005055 ()
  • 00859389005058 ()

  • Width: 7 Centimeter
  • Height: 4 Centimeter


  • Cardiovascular patch, animal-derived

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.
AZIYO BIOLOGICS, INC.
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.
AZIYO BIOLOGICS, INC.
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.
AZIYO BIOLOGICS, INC.
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.
AZIYO BIOLOGICS, INC.
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.
AZIYO BIOLOGICS, INC.
CMCV-059-401
In Commercial Distribution

  • 00859389005003 ()
  • 10859389005000 ()

  • Height: 10 Centimeter
  • Width: 7 Centimeter


  • Cardiovascular patch, animal-derived

CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 7cm x 10cm - 00850003965017

CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
CORMATRIX CARDIOVASCULAR, INC.
CMCP5P-710
In Commercial Distribution

  • 00850003965017 ()

  • Width: 10 Centimeter
  • Length: 7 Centimeter


  • Cardiovascular patch, animal-derived
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