Duns Number:049735438
Device Description: ReliaMed Sterile Bordered Gauze Dressing 4" x 8"
Catalog Number
ZGB48
Brand Name
RELIAMED
Version/Model Number
ZGB48
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
3b2461d4-7686-4d7c-9597-260fe210f547
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
May 17, 2019
Package DI Number
20888499000589
Quantity per Package
25
Contains DI Package
00888499000585
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 |