Catalog Number

11874

Brand Name

1000 ForTec Thulium TFL Laser Fiber

Version/Model Number

FT-1000S-RT-00C-BLK-1

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

d550f7fb-a61e-417f-8710-1a6a68a0b997

Public Version Date

July 14, 2021

Public Version Number

1

DI Record Publish Date

July 06, 2021

Package DI Number

00810077635759

Quantity per Package

5

Contains DI Package

00810077630754

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton