Duns Number:152165817
Device Description: TRANSCYTE® is a human fibroblast-derived temporary skin substituteconsisting of a polymer TRANSCYTE® is a human fibroblast-derived temporary skin substituteconsisting of a polymer membrane and donated neonatal humanfibroblast cells cultured under aseptic conditions in vitro on a nylonmesh. Prior to cell growth, this nylon mesh is coated with porcinedermal collagen and bonded to a polymer membrane (silicone). Thismembrane provides a transparent synthetic epidermis when applied.As fibroblasts proliferate within the nylon mesh, they secrete humandermal collagen, matrix proteins and growth factors. Following freezing,no cellular metabolic activity remains; however, the tissue matrix andbound growth factors are left intact. The human fibroblast-derivedtemporary skin substitute provides a temporary protective barrier.TRANSCYTE is transparent and allows direct visual monitoring of thewound bed.
Catalog Number
-
Brand Name
TransCyte
Version/Model Number
10633
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
BP960700
Product Code
MGR
Product Code Name
Dressing, Wound And Burn, Interactive
Public Device Record Key
d55af25a-ae34-474d-8225-2b0de0781efa
Public Version Date
December 03, 2019
Public Version Number
4
DI Record Publish Date
January 12, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 19 |