Catalog Number

-

Brand Name

NA

Version/Model Number

Laser Surgery Fiber - Chirurgie Bare Fiber 320µm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K140470

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

77fbdc03-057e-4836-8bb8-ce9e80370fad

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

January 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-