Duns Number:809784593
Device Description: Unna-FLEX® Elastic Unna Boot - 4" X 10 Yds.
Catalog Number
650941
Brand Name
UNNA-FLEX
Version/Model Number
650941
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"
-
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
28a56702-e25c-4cb0-81b2-ffd3ea06d5bf
Public Version Date
October 31, 2022
Public Version Number
3
DI Record Publish Date
September 05, 2022
Package DI Number
10768455107640
Quantity per Package
12
Contains DI Package
00768455107643
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |