Duns Number:135057938
Device Description: BARD® Carotid Bypass Shunt, Straight Carotid Shunt One Side Hole Each End, 12F x 13cm
Catalog Number
000681
Brand Name
BARD®
Version/Model Number
000681
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
-
Product Code
DWF
Product Code Name
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Public Device Record Key
89b56c59-90f7-4312-873f-36810b9276ee
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
10801741090087
Quantity per Package
5
Contains DI Package
00801741090080
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |