Catalog Number

-

Brand Name

Flex-X

Version/Model Number

11278VSUE

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

-

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

K141250

Product Code

FGB

Product Code Name

Ureteroscope and accessories, flexible/rigid

Public Device Record Key

69ab09b7-bd18-4ac3-af21-b666ea861866

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

January 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-