Duns Number:796253292
Device Description: SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes, shapes, and thicknesses to be trimmed by the physician to meet the individual patient's needs.
Catalog Number
606-300-016
Brand Name
SurgiMend®
Version/Model Number
606-300-016
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
K083898
Product Code
FTM
Product Code Name
Mesh, surgical
Public Device Record Key
357b2dee-8c5c-4497-bf89-1d6a7dd47073
Public Version Date
October 04, 2022
Public Version Number
8
DI Record Publish Date
October 14, 2015
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. | 81 |
| U | Unclassified | 55 |