Duns Number:140727624
Device Description: Vascuclamp Radiopaque Vascular Clamp Large Straight (2 Clamps Per Package)
Catalog Number
046-1-400
Brand Name
Vascuclamp
Version/Model Number
046-1-400
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
K771701,K771701,K771701
Product Code
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
99ffde14-d872-4265-9110-2a7c7aa319b9
Public Version Date
July 27, 2022
Public Version Number
1
DI Record Publish Date
July 19, 2022
Package DI Number
10886333222428
Quantity per Package
5
Contains DI Package
00886333222421
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |