Duns Number:016898496
Device Description: Interglide™ Pediatric Coated Intermittent Catheter
Catalog Number
431010
Brand Name
Bard® Interglide™ Intermittent Catheter
Version/Model Number
431010
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
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
048c9e25-8a61-4186-bcf7-fb424b70db59
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 23, 2016
Package DI Number
10801741077996
Quantity per Package
25
Contains DI Package
00801741077999
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 |