Duns Number:041674552
Device Description: Conforming Gauze, Sterile, 3" X 4.1yd
Catalog Number
Not Applicable
Brand Name
MedSource Gauze
Version/Model Number
MS-GZCS3
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
dfcc9078-0b11-4782-aaf3-390b079ec64b
Public Version Date
December 28, 2021
Public Version Number
3
DI Record Publish Date
August 03, 2021
Package DI Number
00840155411982
Quantity per Package
12
Contains DI Package
00840155411944
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 | 498 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |