Duns Number:092364462
Device Description: BD: Gauze 18x36 8Ply 100/Cs
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
12-918-59
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
NAB
Product Code Name
Gauze/sponge,nonresorbable for external use
Public Device Record Key
5593f087-b558-4668-84aa-da8588fba4bf
Public Version Date
August 24, 2021
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
20809160004361
Quantity per Package
100
Contains DI Package
10809160004364
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |