Catalog Number

-

Brand Name

Typenex Surgical Single Use Optical Fiber

Version/Model Number

MF200ST205

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

a34d9eff-4011-4643-a617-c6c41ad76c10

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

August 25, 2016

Package DI Number

B050MF200ST2051

Quantity per Package

5

Contains DI Package

B050MF200ST2050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton