Catalog Number

11718

Brand Name

400 KTP Laser Fiber

Version/Model Number

FT-0400S-FT-000-AUR-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

-

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

667291f3-5e36-4d16-ab89-aa2de4e116ca

Public Version Date

May 27, 2021

Public Version Number

1

DI Record Publish Date

May 19, 2021

Package DI Number

00810077635605

Quantity per Package

5

Contains DI Package

00810077630600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton