Catalog Number

LATHE402.4

Brand Name

Doctor Diode Laser

Version/Model Number

Optical tip

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102036,K102036

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

110c389d-e7f3-4c9c-a003-9899ff9ab09f

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

December 01, 2016

Package DI Number

18056093611042

Quantity per Package

4

Contains DI Package

08056093611045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box