Catalog Number

AACO15061980BDAZ0003

Brand Name

Hybrid System 70W 120V 50/60 HZ

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 11, 2021

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K203441

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

7e972c3f-a5fb-46a5-b541-26b7253ddb32

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-