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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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DuraGen XS™ Dural Regeneration Matrix - 10381780070955

DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Integra Lifesciences Corporation
DXM1013
In Commercial Distribution

  • 10381780070955 ()
  • M269DXM10131 ()

  • 1 in x 3 in 2.5 cm x 7.5 cm
DXM1013

  • Dura mater graft, bovine

Supple Peri-Guard - 00085412530710

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.
PC1016SN
In Commercial Distribution

  • 00085412530710 ()
PC1016SNBIO

  • Cardiovascular patch, animal-derived

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

Integra® External Fixation System - 10381780125662

The Integra External Fixation System half ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224143
In Commercial Distribution

  • 10381780125662 ()

  • 220 mm inner dia
12224143

  • External orthopaedic fixation system, reusable

Integra® External Fixation System - 10381780125655

The Integra External Fixation System 5/8 ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224141
In Commercial Distribution

  • 10381780125655 ()

  • 220 mm inner dia
12224141

  • External orthopaedic fixation system, reusable

Integra® External Fixation System - 10381780125648

The Integra External Fixation System half ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224133
In Commercial Distribution

  • 10381780125648 ()

  • 200 mm inner dia
12224133

  • External orthopaedic fixation system, reusable

Integra® External Fixation System - 10381780125631

The Integra External Fixation System full ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224132
In Commercial Distribution

  • 10381780125631 ()

  • 200 mm inner dia
12224132

  • External orthopaedic fixation system, reusable

Integra® External Fixation System - 10381780125624

The Integra External Fixation System 5/8 ring is used for stability and structure. It is manufactured from aluminum. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224131
In Commercial Distribution

  • 10381780125624 ()

  • 200 mm inner dia
12224131

  • External orthopaedic fixation system, reusable
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