Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-8312

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K050887,K050887,K050887

Product Code

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Public Device Record Key

f6257f68-eb24-4145-9d65-3f1f5cd4aad6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

40612479188547

Quantity per Package

4

Contains DI Package

20612479188536

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case