Duns Number:088528245
Device Description: Two-Layer Compression KitLayer 1 is a soft foam roll with odor and itch control properties Two-Layer Compression KitLayer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. AndoFlex® TLC provides a two-step level of comfort W/IND 4"
Catalog Number
ASP-7805TLC-TN
Brand Name
AndoFlex TLC
Version/Model Number
W/IND 4"
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
6009a337-e052-47ef-946d-63315284ea87
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 05, 2022
Package DI Number
00724004614925
Quantity per Package
8
Contains DI Package
10724004614922
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 |