Duns Number:528104096
Device Description: BGEcare Sterile Gauze Sponge 3''X3'', 8-Ply, 2 pieces/pack, 50 packs/box, 24 boxes/carton BGEcare Sterile Gauze Sponge 3''X3'', 8-Ply, 2 pieces/pack, 50 packs/box, 24 boxes/carton box
Catalog Number
-
Brand Name
BGEcare Sterile Gauze Sponge
Version/Model Number
GS01030308025024S
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
9f14f803-3371-407c-920a-0f83a4ed9133
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
March 11, 2021
Package DI Number
06972403301029
Quantity per Package
50
Contains DI Package
06972403301012
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 | 9 |