UBZ - Two-Layer KitLayer 1 is a soft foam roll - Andover Healthcare, Inc.

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. CoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market.WHT SINGLE RL 3" X 6 Yds

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More Product Details

Catalog Number

UB830Z-01

Brand Name

UBZ

Version/Model Number

WHT SINGLE RL 3" X 6 Yds

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

8a90ea6a-e6ae-46ee-a7e0-220cee1a2b17

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 05, 2022

Additional Identifiers

Package DI Number

00724004613669

Quantity per Package

12

Contains DI Package

10724004613666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ANDOVER HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 55