Duns Number:031284586
Device Description: Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.
Catalog Number
TKS2
Brand Name
GEM BIOVER Microvascular Clamp
Version/Model Number
TKS2
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
-
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
b96f80bb-9702-44cf-be0c-9b1201a48622
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 19, 2022
Package DI Number
10844735006343
Quantity per Package
10
Contains DI Package
00844735006346
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |