Duns Number:049735438
Device Description: Sterile Latex-Free Hydrocolloid Sacral Dressing with Film Back and Beveled Edge 6" x 7"
Catalog Number
ZDHC67SB
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZDHC67SB
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
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
260d7169-0657-4abf-a24e-5f3763c1b0d2
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
May 13, 2019
Package DI Number
50885380109858
Quantity per Package
16
Contains DI Package
20885380109857
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 |