Catalog Number

M290400S

Brand Name

FiberTech®

Version/Model Number

FT IR400T-3/SGFM-F 000031L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K050738,K050738,K050738

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

55ecb864-df74-42a9-98bb-8ccfd6a1766a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 29, 2016

Package DI Number

04260438610417

Quantity per Package

5

Contains DI Package

04260438610035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-