Gemini EVO - Refill/accessory for International Power supply - AZENA MEDICAL, LLC

Duns Number:073483242

Device Description: Refill/accessory for International Power supply for Gemini EVO

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More Product Details

Catalog Number

G2-5-005

Brand Name

Gemini EVO

Version/Model Number

9126

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

e4df2f79-52f1-4cb6-85ca-e74d250fc3a5

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AZENA MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10