Catalog Number

-

Brand Name

LiNA OperaScope™ with HDMI cable

Version/Model Number

OP-200-6

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

0c51556d-a792-4519-a7c8-9b3f5d3cf17a

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 04, 2020

Package DI Number

05708265012381

Quantity per Package

6

Contains DI Package

05708265012374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box