Duns Number:041674552
Device Description: Non Sterile Gauze 4x4 8ply
Catalog Number
Not Applicable
Brand Name
MedSource Gauze
Version/Model Number
MS-GZ4X4NS
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
8f3afdc0-295b-4cec-8ed9-ed1084fe5e7f
Public Version Date
January 05, 2022
Public Version Number
4
DI Record Publish Date
August 03, 2021
Package DI Number
00840155411920
Quantity per Package
4000
Contains DI Package
00840155411913
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |