MultiPulse PRO DUO - The MultiPulse PRO DUO is a medical laser system - EL.EN. SPA

Duns Number:436887608

Device Description: The MultiPulse PRO DUO is a medical laser system equipped with a 60W CO2 laser source deli The MultiPulse PRO DUO is a medical laser system equipped with a 60W CO2 laser source delivered either through articulated arm or through a hollow fiber.

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More Product Details

Catalog Number

M110P1

Brand Name

MultiPulse PRO DUO

Version/Model Number

M110P1

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

534a13ce-78e9-474f-b523-83c22cee8b91

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 07, 2021

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