Duns Number:796253292
Device Description: TissueMend is a remodelable collagen matrix derived from bovine skinto be used to reinforc TissueMend is a remodelable collagen matrix derived from bovine skinto be used to reinforce soft tissues where weakness exists. Thedevice is supplied sterile and is provided in sheet form in a varietysizes to be trimmed and sutured by the surgeon to meet the individualpatient's needs.
Catalog Number
6495-9-006
Brand Name
TissueMend
Version/Model Number
6495-9-006
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)
-
FDA Premarket Submission
K060989
Product Code
FTM
Product Code Name
Mesh, surgical
Public Device Record Key
8a94d49c-26f0-4ff0-ac35-59cdff22f904
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 |