Diode Laser Wolf 445nm - Wolf 445nm, Diode Laser, Aiming Beam 532nm, - A.R.C. Laser GmbH

Duns Number:314885641

Device Description: Wolf 445nm, Diode Laser, Aiming Beam 532nm, Coupling U.C.

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More Product Details

Catalog Number

LS11000

Brand Name

Diode Laser Wolf 445nm

Version/Model Number

LS11000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

6f3dc886-fa9e-44e8-a1d0-de148cb39d60

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 09, 2020

Additional Identifiers

Package DI Number

04260155592553

Quantity per Package

1

Contains DI Package

04260155592546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"A.R.C. LASER GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5