Duns Number:049735438
Device Description: ReliaMed Sterile Composite Barrier Dressing 6" x 6" with 4" x 4" Pad
Catalog Number
ZGC66
Brand Name
RELIAMED
Version/Model Number
ZGC66
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
61d48ff7-8d6c-41e2-a5f3-76b49493b166
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
May 20, 2019
Package DI Number
20888499000619
Quantity per Package
25
Contains DI Package
00888499000615
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 | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |