Catalog Number

MDS200650C

Brand Name

Medline

Version/Model Number

MDS200650C

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

01ab66e6-6fef-4b4f-b0bd-d97c0363cffc

Public Version Date

December 31, 2020

Public Version Number

1

DI Record Publish Date

December 23, 2020

Package DI Number

20080196323828

Quantity per Package

250

Contains DI Package

10080196323821

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK