Catalog Number

-

Brand Name

NA

Version/Model Number

AA63000

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"

Yes

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

K021696,K021696

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

afa49083-99db-41f1-a187-9a023aecc331

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 09, 2018

Package DI Number

M735AA630005

Quantity per Package

10

Contains DI Package

M735AA630001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-