Duns Number:594540572
Device Description: Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
Catalog Number
629302
Brand Name
Endoform Antimicrobial Dermal Template
Version/Model Number
629304
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,K172318
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
1d58cbbb-bc89-430b-8b0f-5540e1442c99
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
June 21, 2019
Package DI Number
09421905067379
Quantity per Package
10
Contains DI Package
09421905067263
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 |