Catalog Number

-

Brand Name

Typenex Surgical Reusable Optical Fiber

Version/Model Number

MF800RST205

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

-

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

8758f43a-cdf4-4fb0-b833-ba71b040701c

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

September 06, 2016

Package DI Number

B050MF800RST2051

Quantity per Package

5

Contains DI Package

B050MF800RST2050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton