Catalog Number

-

Brand Name

Typenex Surgical Single Use Optical Fiber

Version/Model Number

MF800ST205

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

d7731c68-5bd3-4283-ab7d-862f3158d859

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

August 26, 2016

Package DI Number

B050MF800ST2051

Quantity per Package

5

Contains DI Package

B050MF800ST2050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton