Catalog Number

-

Brand Name

INVISIO®DIGITAL FLEXIBLE CYSTONEPHROSCOPE Backward Articulating 5.5 m

Version/Model Number

REXICN-2BA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 06, 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

K042225

Product Code

FAJ

Product Code Name

Cystoscope and accessories, flexible/rigid

Public Device Record Key

4aae6334-a826-41f5-8083-cc2b5de7e897

Public Version Date

October 06, 2022

Public Version Number

4

DI Record Publish Date

May 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-