Catalog Number

MDS200425

Brand Name

Medline

Version/Model Number

MDS200425

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

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

98fa6627-f66f-492d-9036-f22e702ebb41

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 02, 2021

Package DI Number

20888277700526

Quantity per Package

30

Contains DI Package

10888277700529

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE