Duns Number:801160037
Device Description: The Skin Graft Mesher is a surgical instrument designed to expand skin grafts.
Catalog Number
-
Brand Name
Brennen Skin Graft Mesher
Version/Model Number
3:1
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FZW
Product Code Name
Expander, Surgical, Skin Graft
Public Device Record Key
34924350-5a03-48ea-a4ee-6d8c7585c903
Public Version Date
August 18, 2022
Public Version Number
1
DI Record Publish Date
August 10, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 3 |