Duns Number:544509489
Device Description: BGEcare Sterile Non-woven Sponge 4"X4", 4-Ply, 2 pieces/pack, 35 packs/box, 20 boxes/carto BGEcare Sterile Non-woven Sponge 4"X4", 4-Ply, 2 pieces/pack, 35 packs/box, 20 boxes/carton box
Catalog Number
-
Brand Name
BGEcare Sterile Non-woven Sponge
Version/Model Number
NS06040404023520S
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
FRL
Product Code Name
Fiber, Medical, Absorbent
Public Device Record Key
2e10a4e8-6830-4d2b-bc7f-22dc0f80752f
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
March 08, 2021
Package DI Number
06972403420119
Quantity per Package
35
Contains DI Package
06972403420102
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 | 5 |