Duns Number:055870299
Device Description: Debakey Hess Atraumatic Bulldog Clamp, Slender Long Jaws,Gentle, Soft Action, 20mm Jaw, 7. Debakey Hess Atraumatic Bulldog Clamp, Slender Long Jaws,Gentle, Soft Action, 20mm Jaw, 7.5cm
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.574326
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
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
c79ac803-b9a7-4392-aada-c99c4727a749
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 29, 2020
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 | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |