Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 86-20PW

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)

-

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

9d3a9c38-b77f-4b1e-98c0-d20c926964ff

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

March 08, 2021

Package DI Number

26931918136193

Quantity per Package

6

Contains DI Package

16931918136196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton