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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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Vascu-Guard - 00085412818634

VASCU-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. VASCU-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.
VG02515
In Commercial Distribution

  • 00085412818634 ()
VG02515

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818610

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. 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.
PG1016
In Commercial Distribution

  • 00085412818610 ()
PG1016

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818597

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. 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.
PG0814
In Commercial Distribution

  • 00085412818597 ()
PG0814

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818573

VASCU-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. VASCU-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.
VG0209
In Commercial Distribution

  • 00085412818573 ()
VG0209

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818559

VASCU-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. VASCU-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.
VG01510
In Commercial Distribution

  • 00085412818559 ()
VG01510

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818535

VASCU-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. VASCU-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.
VG0114
In Commercial Distribution

  • 00085412818535 ()
VG0114

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818511

VASCU-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. VASCU-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.
VG0110
In Commercial Distribution

  • 00085412818511 ()
VG0110

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818498

VASCU-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. VASCU-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.
VG0108
In Commercial Distribution

  • 00085412818498 ()
VG0108

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818474

VASCU-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. VASCU-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.
VG0106
In Commercial Distribution

  • 00085412818474 ()
VG0106

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818443

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. 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.
PG0608
In Commercial Distribution

  • 00085412818443 ()
PG0608

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818429

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.
SPG1016
In Commercial Distribution

  • 00085412818429 ()
SPG1016

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818375

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.
SPG0814
In Commercial Distribution

  • 00085412818375 ()
SPG0814

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818313

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.
SPG0608
In Commercial Distribution

  • 00085412818313 ()
SPG0608

  • Cardiovascular patch, animal-derived

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)

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)

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

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

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 - 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

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

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 - 07640178982765

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

  • 07640178982765 ()
JLL-IN 08 01-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

CxHA™ - M711LS4590

Polypropylene
Innovasis, Inc.
LS-459
In Commercial Distribution

  • M711LS4590 ()
LS-459

  • Bone graft packing block
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