Duns Number:594540572
Device Description: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-deriv Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
Catalog Number
529313
Brand Name
Endoform™ Natural Restorative Bioscaffold
Version/Model Number
529313
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"
Yes
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)
-
FDA Premarket Submission
K092096,K092096
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
6ea1a4cd-578d-4ff2-bbbb-63720f2bb7b4
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 20, 2021
Package DI Number
09421906017373
Quantity per Package
10
Contains DI Package
09421906017267
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |
| U | Unclassified | 33 |