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.NL W/IND TN/WH 3"

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More Product Details

Catalog Number

8830UBZ-TN

Brand Name

UBZ

Version/Model Number

NL W/IND TN/WH 3"

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

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 Details

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

b70cc102-3665-4b2e-bbd1-ecfe9557347e

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 05, 2022

Additional Identifiers

Package DI Number

00724004611856

Quantity per Package

8

Contains DI Package

10724004611853

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