Catalog Number

OP‐201‐6

Brand Name

LiNA OperåScope™ with HDMI cable & LCD

Version/Model Number

OP‐201‐6

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

Yes

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

-

Product Code

HIH

Product Code Name

Hysteroscope (And Accessories)

Public Device Record Key

62bfbb83-a358-4896-bd10-99822475bbd0

Public Version Date

March 05, 2020

Public Version Number

3

DI Record Publish Date

November 13, 2018

Package DI Number

05708265010950

Quantity per Package

6

Contains DI Package

05708265010943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box