Catalog Number

-

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

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

ba65e0ab-d85d-4e0b-b5ca-56f60f5d2fe7

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Package DI Number

05708265013913

Quantity per Package

6

Contains DI Package

05708265013906

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-