Catalog Number

-

Brand Name

Gemini EVO

Version/Model Number

9120

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

K210350

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

be0e4791-bc3b-4216-afd7-34db30399ce8

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-