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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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INTEGRA Dermal Regeneration Template 4in. x 10in. (10cm x 25cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
34105
In Commercial Distribution

  • M269341051 ()
  • 10381780000594 ()
  • 00381780000597 ()

  • 4 in x 10 in
34105

  • Collagen wound matrix dressing
Integra® Dermal Regeneration Template 4in. x 10in.
Integra Lifesciences Corporation
34041
In Commercial Distribution

  • M269341011 ()
  • 10381780000587 ()

  • 4 in x 10 in
34041

  • Collagen wound matrix dressing
INTEGRA Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
34055
In Commercial Distribution

  • M269340551 ()
  • 10381780000570 ()
  • 00381780000573 ()

  • 4 in x 5 in
34055

  • Collagen wound matrix dressing
Integra® Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm)
Integra Lifesciences Corporation
34051
In Commercial Distribution

  • M269340511 ()
  • 10381780000563 ()

  • 4 in x 5 in
34051

  • Collagen wound matrix dressing
BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10141 ()
  • B115ABCARDA10140 ()
ABCardA-10-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10141 ()
  • B115ABCARD10140 ()
ABCard-10-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Roche Diagnostics GmbH
04927931160
Not in Commercial Distribution

  • 04015630923045 ()
04927931160

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
04927826160
Not in Commercial Distribution

  • 04015630923038 ()
04927826160

  • Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
03289796190
In Commercial Distribution

  • 04015630919338 ()
03289796190

  • Free (unbound) prostate specific antigen (fPSA) IVD, calibrator
No Description
Roche Diagnostics GmbH
03289788160
Not in Commercial Distribution

  • 04015630919321 ()
03289788160

  • Free (unbound) prostate specific antigen (fPSA) IVD, control
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