Duns Number:544509489
Device Description: BGEcare Self Adhesive Non-woven Bandage, 2in X 5yards, 1 roll/OPP film, 36 rolls/box, 6 bo BGEcare Self Adhesive Non-woven Bandage, 2in X 5yards, 1 roll/OPP film, 36 rolls/box, 6 boxes/carton box
Catalog Number
-
Brand Name
BGEcare Self Adhesive Non-woven Bandage
Version/Model Number
CB080205011806NS
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
47463108-eea2-4b8c-b0a7-da9fc3277fcb
Public Version Date
March 16, 2021
Public Version Number
1
DI Record Publish Date
March 08, 2021
Package DI Number
06972403420058
Quantity per Package
36
Contains DI Package
06972403420041
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 |