Catalog Number

-

Brand Name

Fibernex

Version/Model Number

LF0201X200

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

K050738,K050738

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

9358fad4-e687-42c5-8717-5c2fd0b1b2b8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 27, 2016

Package DI Number

B050LF0201X2003

Quantity per Package

5

Contains DI Package

B050LF0201X2000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton