Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-82420

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

FFQ

Product Code Name

Speculum, Rectal

Public Device Record Key

bf7eac51-4bf5-4263-8a17-8af88d261049

Public Version Date

July 29, 2020

Public Version Number

1

DI Record Publish Date

July 21, 2020

Package DI Number

40612479224955

Quantity per Package

4

Contains DI Package

20612479224944

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case