Duns Number:016898496
Device Description: Bard® Ureteral Catheter Adapter
Catalog Number
140000
Brand Name
Bard® Ureteral Catheter Adapter
Version/Model Number
140000
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"
Yes
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
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
6f6b2fc5-fe3a-4600-a125-de4f92380402
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 11, 2017
Package DI Number
20801741130476
Quantity per Package
24
Contains DI Package
10801741130479
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 | 472 |
2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
U | Unclassified | 10 |