Dornier MedTech - Dornier SmartFlex 400 High Energy Laser Fiber - - DORNIER MEDTECH AMERICA, INC.

Duns Number:130789944

Device Description: Dornier SmartFlex 400 High Energy Laser Fiber - Dornier Direct

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More Product Details

Catalog Number

HOL400RHE

Brand Name

Dornier MedTech

Version/Model Number

400 Micron Reusable HE

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

K123385,K123385

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

9e640bb3-6235-468b-8b81-61b02f459a8d

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

October 16, 2019

Additional Identifiers

Package DI Number

00810116021109

Quantity per Package

3

Contains DI Package

00810116021055

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