Catalog Number

IL-100-100-900

Brand Name

Gynescope system, cart

Version/Model Number

01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K190187

Product Code

HEX

Product Code Name

Colposcope (And Colpomicroscope)

Public Device Record Key

94d7f38b-78a0-42e6-8b9d-ef69c4638eee

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

November 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-