Duns Number:848522678
Device Description: VATS Debakey Clamp - 10mm Shaft 100mm Debakey 1x2 Jaws, Curved Left 10" WL, 14-1/4" OL, Wi VATS Debakey Clamp - 10mm Shaft 100mm Debakey 1x2 Jaws, Curved Left 10" WL, 14-1/4" OL, With Ratchet
Catalog Number
67-2162
Brand Name
Boss Instruments
Version/Model Number
67-2162
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
74b62b53-8ebc-4594-be0f-dc871f79bd4e
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3026 |