Catalog Number

-

Brand Name

Gemini 810+980 Diode Laser Kit, International

Version/Model Number

8990

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 22, 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"

-

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

K192617

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

b4319f84-e644-4782-8688-52108d0d26cb

Public Version Date

July 30, 2021

Public Version Number

1

DI Record Publish Date

July 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-