Duns Number:961027315
Device Description: SELF ADHERENT BANDAGE 2IN X 5YD NONSTERILE LATEX 1CA/6BX/12EA SOFT BREATHABLE LIGHTWEIGHT
Catalog Number
CAH25
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH25
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
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
FQM
Product Code Name
BANDAGE, ELASTIC
Public Device Record Key
b2d5c8d0-731e-44d0-a58f-0ab7a8e0cc91
Public Version Date
July 19, 2019
Public Version Number
1
DI Record Publish Date
July 11, 2019
Package DI Number
50885380004382
Quantity per Package
6
Contains DI Package
20885380004381
Package Discontinue Date
-
Package Status
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 |