Catalog Number

-

Brand Name

Floorstand base

Version/Model Number

OCS5-STB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K852980

Product Code

HEX

Product Code Name

COLPOSCOPE (AND COLPOMICROSCOPE)

Public Device Record Key

470dd58b-a864-49d6-b298-66543b2027df

Public Version Date

February 22, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-