Catalog Number

-

Brand Name

ProFlex™

Version/Model Number

Laser Lithotripsy Fiber

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 2016

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

K142638

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

8de22d09-2e96-4c87-9c53-b25759a06014

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

November 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-