Catalog Number

11609

Brand Name

200 Excalibur Laser Fiber

Version/Model Number

FT-0200S-FT-STO-FOR-2

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

fc92a8e2-cdec-4b05-a3d3-8702a8186f6d

Public Version Date

May 19, 2021

Public Version Number

1

DI Record Publish Date

May 11, 2021

Package DI Number

00810077632017

Quantity per Package

1

Contains DI Package

00810077630563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton