Duns Number:799240457
Device Description: Coronary Bypass Vein Clamp (non-sterile)
Catalog Number
-
Brand Name
Voss Coronary Bypass Vein Clamp
Version/Model Number
82931-NS
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
K885161
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
e9e2888b-05e6-422a-b44d-a7d6d2b20caa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 05, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |