Catalog Number

PRM25493

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

PRM25493

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)

-

Over the Counter (OTC)

Yes

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

abe67840-1ee3-418a-8685-c0a0bcfd0e76

Public Version Date

January 27, 2021

Public Version Number

1

DI Record Publish Date

January 19, 2021

Package DI Number

20080196694065

Quantity per Package

12

Contains DI Package

10080196694068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG