Duns Number:118492643
Device Description: Battle Bandage1 ea. - 8" x 8", sterile gauze pad with 6' x 4", clear, self adhering, compr Battle Bandage1 ea. - 8" x 8", sterile gauze pad with 6' x 4", clear, self adhering, compression wrap
Catalog Number
32-700
Brand Name
BATTLE BANDAGE
Version/Model Number
06
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
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
2da08da0-f0aa-4fc1-b8f9-d75966f69e16
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |