Duns Number:961027315
Device Description: SELF ADHERENT BANDAGE 3IN X 5YD NONSTERILE LATEX FREE 1CA/4BX/12EA SOFT BREATHABLE LIGHTWE SELF ADHERENT BANDAGE 3IN X 5YD NONSTERILE LATEX FREE 1CA/4BX/12EA SOFT BREATHABLE LIGHTWEIGHT ASSORTED COLOR PACK
Catalog Number
CAH35LFCP
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH35LFCP
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
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
19159743-fa49-40a0-9ff0-67faf53ef6dc
Public Version Date
July 19, 2019
Public Version Number
1
DI Record Publish Date
July 11, 2019
Package DI Number
20885380004206
Quantity per Package
12
Contains DI Package
00885380004202
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 |