Duns Number:544509489
Device Description: BGEcare Elastic Bandage with Self-closure, 4in X 5 yards, Latex Free,12 rolls/box, 6 boxes BGEcare Elastic Bandage with Self-closure, 4in X 5 yards, Latex Free,12 rolls/box, 6 boxes/carton box
Catalog Number
-
Brand Name
BGEcare Elastic Bandage with Self-closure
Version/Model Number
EB070405011206NS
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
01fe2946-eedb-4a87-b350-a145b74a9ed3
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
March 08, 2021
Package DI Number
06972403420034
Quantity per Package
6
Contains DI Package
06972403420027
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |