Catalog Number

-

Brand Name

SU-200-TRUE

Version/Model Number

11704

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

b828ed0d-5dd3-41c0-a490-d604a9af528d

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 29, 2018

Package DI Number

B145117371

Quantity per Package

5

Contains DI Package

B145117040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton