Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-158

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

-

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

EPY

Product Code Name

Speculum, Ent

Public Device Record Key

db47ec85-1324-4ba3-a2f4-fd98c7cee935

Public Version Date

July 20, 2020

Public Version Number

1

DI Record Publish Date

July 10, 2020

Package DI Number

40612479195026

Quantity per Package

10

Contains DI Package

20612479195015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case