Duns Number:079241502
Device Description: Gauze Sponge, 2" x 2", 12-PLY, Non-Sterile, (200/PK, 8,000/CS)
Catalog Number
-
Brand Name
Wound-Care
Version/Model Number
WC9012241
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"
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
d98cd28b-f24f-45db-a10c-a74f7327430f
Public Version Date
December 29, 2020
Public Version Number
1
DI Record Publish Date
December 21, 2020
Package DI Number
G018WC90122412
Quantity per Package
40
Contains DI Package
G018WC90122411
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |