Duns Number:961027315
Device Description: SELF ADHERENT BANDAGE 4IN X 5YD NONSTERILE LATEX 1CA/6BX/12EA SOFT BREATHABLE LIGHTWEIGHT
Catalog Number
CAH45
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH45
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
7a28148a-9f23-4383-b3e5-1d64251d5411
Public Version Date
July 19, 2019
Public Version Number
1
DI Record Publish Date
July 11, 2019
Package DI Number
20885380004404
Quantity per Package
18
Contains DI Package
00885380004400
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |