Catalog Number

-

Brand Name

Galileo Colposcope, Direct Access

Version/Model Number

200DA-R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061306

Product Code

HEX

Product Code Name

Colposcope (And Colpomicroscope)

Public Device Record Key

ef873946-d73f-4083-a936-7a07cac91c05

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-