Catalog Number

-

Brand Name

MFR-550/600-HHz

Version/Model Number

MFR-550/600-HHz

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

K124003

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

c7d423d4-4921-4b11-954a-b52c632b6e01

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

August 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-