Duns Number:049735438
Device Description: ReliaMed Sterile Composite Barrier Dressing 4" x 4" with 2" x 2" Pad
Catalog Number
ZGC44
Brand Name
RELIAMED
Version/Model Number
ZGC44
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
ff5d12d6-40af-42c0-8b22-a13f575666b1
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
May 17, 2019
Package DI Number
50888499000603
Quantity per Package
18
Contains DI Package
20888499000602
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 |