Duns Number:796253292
Device Description: RevizeTM-X Collagen Matrix for Soft Tissue Reconstruction
Catalog Number
611-005-001
Brand Name
RevizeTM-X
Version/Model Number
611-005-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K171357
Product Code
FTM
Product Code Name
Mesh, surgical
Public Device Record Key
cdc6049c-bfd2-4403-ac84-ad86948f0d71
Public Version Date
August 26, 2022
Public Version Number
6
DI Record Publish Date
October 23, 2017
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 |