Duns Number:088528245
Device Description: Two-Layer KitLayer 1 is a soft foam roll impregnated with zinc that soothes and calms skin Two-Layer KitLayer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features EasyTear technology, eliminating the need for scissors. AndoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market.4"W/IN TN 3
Catalog Number
ASP-8830UBZ-TN
Brand Name
AndoFlex UBZ
Version/Model Number
4"W/IN TN 3
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)
Yes
Over the Counter (OTC)
-
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
6552e3c0-40f0-4353-b2ae-860161fd473d
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 05, 2022
Package DI Number
00724004620889
Quantity per Package
8
Contains DI Package
10724004620886
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 | 55 |