Duns Number:961027315
Device Description: NON-ADHERENT PAD 3X8IN NON-STER, LF
Catalog Number
BNS-DD38
Brand Name
CARDINAL HEALTH
Version/Model Number
BNS-DD38
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
dd823e0c-a8cc-4bbb-8bac-110e31e9e271
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
July 11, 2019
Package DI Number
50885380054110
Quantity per Package
20
Contains DI Package
20885380054119
Package Discontinue Date
December 31, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |