Catalog Number

-

Brand Name

Fraxis 1.1 Set Package

Version/Model Number

Fraxis 1.1 Set Package

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172096

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

6342d16b-fa98-4a68-a13d-b9b737889d25

Public Version Date

April 13, 2022

Public Version Number

1

DI Record Publish Date

April 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-