Catalog Number

K2011822

Brand Name

Dornier MedTech

Version/Model Number

400 Micron Disposable NA 0.37

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

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

K991183,K991183

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

00611f60-5124-4ae0-823f-fb8fb6566270

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 13, 2018

Package DI Number

04049958002137

Quantity per Package

10

Contains DI Package

04049958002120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box