Catalog Number

A22003A

Brand Name

Olympus

Version/Model Number

A22003A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2020

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

K897003

Product Code

HIH

Product Code Name

Hysteroscope (And Accessories)

Public Device Record Key

47ecb8e1-b932-4709-837d-8f50705acc4e

Public Version Date

August 04, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-