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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 8in. x 10in. (20cm 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
38105
In Commercial Distribution

  • M269381051 ()
  • 10381780000617 ()
  • 00381780000610 ()

  • 8 in x 10 in
38105

  • Animal-derived wound matrix dressing
Integra® Dermal Regeneration Template 8in. x 10in. (20cm x 25cm)
Integra Lifesciences Corporation
38101
In Commercial Distribution

  • M269381011 ()
  • 10381780000600 ()

  • 8 in x 10 in
38101

  • Animal-derived wound matrix dressing
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

  • Animal-derived 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

  • Animal-derived wound matrix dressing
No Description
Paradigm Spine GmbH
UET00010
In Commercial Distribution

  • 04260148898884 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
N/A
COCHLEAR LIMITED
Z544996
In Commercial Distribution

  • 09321502038492 ()
  • 09321502043014 ()

  • Outer Diameter: 10 Millimeter
  • 10mm diameter dome
Z544996

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z545001
In Commercial Distribution

  • 09321502038447 ()
  • 09321502043045 ()

  • 10mm diameter dome
  • Outer Diameter: 10 Millimeter
Z545001

  • Earmould, preformed
Septal Occluder
AGA MEDICAL CORPORATION
9-ASD-010
In Commercial Distribution

  • 05415067019189 ()

  • Outer Diameter: 10 Millimeter
9-ASD-010

  • Cardiac defect occluder
Blood pump PU valves; 10 mL in/out; Ø 6 mm
Berlin Heart GmbH
P10P-001
In Commercial Distribution

  • 04260090040102 ()

  • Total Volume: 10 Milliliter


  • External ventricular circulatory assist system
Proximal Spacer
CONSENSUS ORTHOPEDICS, INC.
1009-0-0010
Not in Commercial Distribution

  • 00844588018244 ()

  • Outer Diameter: 10 Millimeter
1009-0-0010

  • Non-constrained polyethylene acetabular liner
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