Catalog Number

K2011915

Brand Name

Dornier MedTech

Version/Model Number

Medilas D MultiBeam (D-Plug)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070536

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

92eec53c-c45a-4cbd-937d-ec468fa5bcf6

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-