Dornier MedTech - 600 micron core/730 micron OD SMA Diode Laser - DORNIER MEDTECH AMERICA, INC.

Duns Number:130789944

Device Description: 600 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters

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More Product Details

Catalog Number

K2311580

Brand Name

Dornier MedTech

Version/Model Number

600 micron single use SMA

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

Yes

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

K083500,K083500

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

37c6bda6-e252-40f9-9801-631056f4618e

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

October 16, 2019

Additional Identifiers

Package DI Number

00810116022595

Quantity per Package

3

Contains DI Package

00810116022588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DORNIER MEDTECH AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 101