Catalog Number

AASP02031603

Brand Name

Diode Alex 755nm

Version/Model Number

1

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

K172193

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

7516afab-34bb-4d79-bc7d-1ae8e9b9a22b

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-