Catalog Number

-

Brand Name

CVS HEALTH

Version/Model Number

715533-69755CV1

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"

-

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

FXF

Product Code Name

Speculum, Illuminated

Public Device Record Key

74d08329-9ad0-46d8-9253-48fe264fd9f1

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

July 29, 2020

Package DI Number

10050428387440

Quantity per Package

24

Contains DI Package

00050428387443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE