Duns Number:040729840
Device Description: COOLEY TANGENTIAL OCCLUSION CLAMP ANGLED JAW ANGLED SHANK
Catalog Number
-
Brand Name
COOLEY TANGENTIAL OCCL CLAMP
Version/Model Number
2100-273
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
K092544
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
a7e85345-28a7-4b98-8bbb-40ba62ce67f5
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
August 22, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |