Duns Number:315018218
Device Description: DE BAKEY ATRAUMATA Vascular Clamp, curved, 9 5/8", (245 mm), toothing DE BAKEY, width: 75 DE BAKEY ATRAUMATA Vascular Clamp, curved, 9 5/8", (245 mm), toothing DE BAKEY, width: 75 mm, titanium, non-sterile, reusable
Catalog Number
FC323T
Brand Name
ATRAUMATA
Version/Model Number
FC323T
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
HXD
Product Code Name
CLAMP
Public Device Record Key
4c0ac648-99b2-4371-b1c0-19ff0c311dcf
Public Version Date
May 04, 2020
Public Version Number
1
DI Record Publish Date
April 24, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |