Catalog Number

-

Brand Name

Surgimedics®

Version/Model Number

9S-6065

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

fcbcf717-c2ee-47d7-8972-d3941d06e47f

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10814716020460

Quantity per Package

5

Contains DI Package

00814716020463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-