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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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Supple Peri-Guard - 00085412530697

SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814SN
In Commercial Distribution

  • 00085412530697 ()
PC0814SNBIO

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412530673

SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608SN
In Commercial Distribution

  • 00085412530673 ()
PC0608SNBIO

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412530642

SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404SN
In Commercial Distribution

  • 00085412530642 ()
PC0404SNBIO

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818696

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0406
In Commercial Distribution

  • 00085412818696 ()
SPG0406

  • Cardiovascular patch, animal-derived

Surgical Connector Kit - 00852184003410

No Description
Synapse Biomedical, Inc.
22-0028
In Commercial Distribution

  • 00852184003410 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Surgical Instrument - 08806390885331

No Description
Jeil Medical Corporation
111-299
In Commercial Distribution

  • 08806390885331 ()


  • Bone graft packing block

Surgical Site Start-up Kit, ALS HDE - 00852184003328

No Description
Synapse Biomedical, Inc.
20-0070
In Commercial Distribution

  • 00852184003328 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Surgimedics® - 00814716020777

Smoke Evacuation Tubing Support Stand
COASTAL LIFE TECHNOLOGIES, INC.
907001
In Commercial Distribution

  • 00814716020777 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020357

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906151
In Commercial Distribution

  • 00814716020357 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020340

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906150
In Commercial Distribution

  • 00814716020340 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020074

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906750
In Commercial Distribution

  • 00814716020074 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020067

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906760
In Commercial Distribution

  • 00814716020067 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020050

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906500
In Commercial Distribution

  • 00814716020050 ()


  • Surgical plume evacuation system

Symbia E Dual Head System - 04056869001159

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


  • Stationary gamma camera system

Symbia E Single Head System - 04056869002729

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10413009
In Commercial Distribution

  • 04056869002729 ()


  • Stationary gamma camera system

Symbia S Series - 04056869001166

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution

  • 04056869001166 ()


  • Stationary gamma camera system

Symbia_Evo - 04056869001258

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910500
In Commercial Distribution

  • 04056869001258 ()


  • Stationary gamma camera system

Symbia_Evo_Excel - 04056869001265

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910501
In Commercial Distribution

  • 04056869001265 ()


  • Stationary gamma camera system

SynCage - 10705034732046

GRAFT PACKING BLOCK-MEDIUM FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.073
In Commercial Distribution

  • 07611819534773 ()
  • H981038250730 ()
  • 10705034732046 ()
03825073

  • Bone graft packing block

SynCage - 10705034732039

GRAFT PACKING BLOCK-SMALL FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.072
In Commercial Distribution

  • 07611819534766 ()
  • H981038250720 ()
  • 10705034732039 ()
03825072

  • Bone graft packing block
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