Catalog Number

098317

Brand Name

NA

Version/Model Number

0400-100-00

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

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

K050738,K050738,K050738

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

b04a6012-0b77-4a92-be60-081f204c10e6

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

May 10, 2019

Package DI Number

02816901021802

Quantity per Package

2

Contains DI Package

01816901021803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-