Duns Number:800149346
Device Description: 1 Cohesive Non-Adhesive Self Adherent Flex Bandage Wrap Non-Sterile Bandage Roll 3" x 5yds
Catalog Number
0104010
Brand Name
Redicare
Version/Model Number
Cohesive Flex Bandage
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
a867c5e4-df5c-43ad-9144-3c3b12e81b3d
Public Version Date
August 05, 2020
Public Version Number
1
DI Record Publish Date
July 28, 2020
Package DI Number
B70901040101
Quantity per Package
96
Contains DI Package
B70901040100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |