Duns Number:049735438
Device Description: Cardinal Health Essentials; Transparent Thin Film Dressing; First Aid Style; 4 in. x 4.75 Cardinal Health Essentials; Transparent Thin Film Dressing; First Aid Style; 4 in. x 4.75 in., Oval
Catalog Number
ZDTFOV4434
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZDTFOV4434
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"
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
52d8e422-235c-4175-a454-b97a90da8ce3
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
Package DI Number
50885380120525
Quantity per Package
200
Contains DI Package
00885380120520
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 | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |