Catalog Number

11805

Brand Name

550 SmartScope LaserFiber

Version/Model Number

FT-0550S-RT-00C-FOR-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

9fca08ab-b65b-456b-b887-b0932b8a784e

Public Version Date

May 27, 2021

Public Version Number

1

DI Record Publish Date

May 19, 2021

Package DI Number

00810077635674

Quantity per Package

5

Contains DI Package

00810077630662

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton