Duns Number:985523874
Device Description: Gauze Sponges 3in X 3in 4-ply
Catalog Number
-
Brand Name
AmerisourceBergen
Version/Model Number
10325
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)
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
42f68be0-0b73-4e75-ba3a-7a96afafc1f4
Public Version Date
October 28, 2021
Public Version Number
1
DI Record Publish Date
October 20, 2021
Package DI Number
60368001103253
Quantity per Package
20
Contains DI Package
00368001103251
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |