Duns Number:009831413
Device Description: PA COTTON GAUZE 4X4 12PLY 2S ST 25/TRAY 24TRAY/CS
Catalog Number
P157025
Brand Name
PRO ADVANTAGE
Version/Model Number
P157025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
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
57dfea78-e9f7-433c-b187-c32cdc2e6dee
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
M220P1570253
Quantity per Package
25
Contains DI Package
M220P1570251
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 | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |