Duns Number:544509489
Device Description: BGEcare Sterile Non-woven Sponge 4"X4", 6-Ply, 2 pieces/pack, 25 packs/box, 12 boxes/carto BGEcare Sterile Non-woven Sponge 4"X4", 6-Ply, 2 pieces/pack, 25 packs/box, 12 boxes/carton box
Catalog Number
-
Brand Name
BGEcare Sterile Non-woven Sponge
Version/Model Number
NS09040406022512S
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
d310f056-206b-45f4-b8af-605a0d81be7a
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
March 08, 2021
Package DI Number
06972403420294
Quantity per Package
25
Contains DI Package
06972403420287
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 |