Catalog Number

510.701.139

Brand Name

Procedure Pack

Version/Model Number

9.5/90

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

K053511,K112154,K053511,K112154

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

71e5fc77-2fdd-4af1-870e-f16e534222a6

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

September 14, 2018

Package DI Number

07640167750788

Quantity per Package

10

Contains DI Package

07640167750245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton