Duns Number:594540572
Device Description: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment and contains approximately 12 µg/cm² (~0.3% w/w) ionic silver, intended to inhibit colonization of the device.
Catalog Number
629302
Brand Name
Endoform™ Antimicrobial Restorative Bioscaffold
Version/Model Number
629302
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172318
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
28a7a930-a93e-4136-9c1a-12e2aec7d9b9
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 20, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |
| U | Unclassified | 33 |