Catalog Number

097512

Brand Name

NA

Version/Model Number

NV0635

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

K050738,K050738,K050738

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

f47b77d6-e586-4252-a6aa-48afd6768db1

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

October 05, 2016

Package DI Number

01816901020479

Quantity per Package

5

Contains DI Package

00816901020470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-