Catalog Number

S365

Brand Name

Trimedyne® FlexMax® 365 µm Single Use Holmium Bare Fiber

Version/Model Number

S365

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

bd19b31b-f9ba-44b6-97d3-68f6d93d7f28

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

July 11, 2018

Package DI Number

M473S3651

Quantity per Package

3

Contains DI Package

M473S3650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton