Catalog Number

HU-FG00961

Brand Name

Tanda

Version/Model Number

Series 4

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080591,K080591,K080591

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

6dc46285-4ee0-4144-a022-ff71584d1cc8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 02, 2017

Package DI Number

20806248005180

Quantity per Package

8

Contains DI Package

10806248005183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-