Duns Number:049735438
Device Description: Self-Adhesive Dressing Retention Sheet; 6 in. x 11 yd; Comfortable, non-woven dressing wit Self-Adhesive Dressing Retention Sheet; 6 in. x 11 yd; Comfortable, non-woven dressing with non-irritating adhesive; Breathable
Catalog Number
ZTDR06
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZTDR06
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
d82fbb6e-8aab-4c56-a970-7c333cdc54fd
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 22, 2019
Package DI Number
50885380122734
Quantity per Package
20
Contains DI Package
00885380122739
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 |