Duns Number:654591569
Device Description: BGEcare Sterile Non-woven Island Dressing, 4''X4'', 1 pieces/pack, 50 packs/box, 12 boxes/ BGEcare Sterile Non-woven Island Dressing, 4''X4'', 1 pieces/pack, 50 packs/box, 12 boxes/carton box
Catalog Number
-
Brand Name
BGEcare Sterile Non-woven Island Dressing
Version/Model Number
ID0404015012S
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
df894695-6d8b-4bc9-8d3b-39b1af5e0c54
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 05, 2021
Package DI Number
06959385794315
Quantity per Package
50
Contains DI Package
06959385794308
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |