Duns Number:009831413
Device Description: PA GAUZE SPONGE 4X4 12PLY NS 200/SLV 10SLV/CS - (CS)
Catalog Number
P157114
Brand Name
Pro Advantage
Version/Model Number
P157114
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)
-
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
fd280a25-33d3-4043-9a20-19a9255d1edb
Public Version Date
October 25, 2022
Public Version Number
1
DI Record Publish Date
October 17, 2022
Package DI Number
M220P1571145
Quantity per Package
10
Contains DI Package
M220P1571143
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 | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |