Duns Number:800149346
Device Description: 25 Fabric Large Patch 2x3 Bandages Latex Free Heavy Weight Wound Protection 25/box
Catalog Number
0103016
Brand Name
Redicare
Version/Model Number
Large Patch Fabric Bandages
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
e1f43079-1854-4653-96cb-9605a37665bf
Public Version Date
August 05, 2020
Public Version Number
1
DI Record Publish Date
July 28, 2020
Package DI Number
B70901030162
Quantity per Package
48
Contains DI Package
B70901030161
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| 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 |