Duns Number:792528510
Device Description: Debakey Vascular Tissue Forcep, Angled, Tip 2.0mm OL 195mm(7 5/8")
Catalog Number
-
Brand Name
Avalign
Version/Model Number
520-13982
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)
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
90e76c86-1320-4298-8bec-91b24c4c53a2
Public Version Date
December 09, 2021
Public Version Number
1
DI Record Publish Date
December 01, 2021
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 | 6832 |
2 | A medical device with a moderate to high risk that requires special controls. | 9482 |