DEKA SmartXide² TRIO C80H - The DEKA SmartXide2 Trio is a medical laser - EL.EN. SPA

Duns Number:436887608

Device Description: The DEKA SmartXide2 Trio is a medical laser system equipped with a 80W CO2 laser source an The DEKA SmartXide2 Trio is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.

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More Product Details

Catalog Number

M103AF1

Brand Name

DEKA SmartXide² TRIO C80H

Version/Model Number

M103AF1

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

K181867

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

af5babc7-88b3-4f1f-aad0-e58e43e2a354

Public Version Date

December 27, 2018

Public Version Number

1

DI Record Publish Date

November 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EL.EN. SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46