Catalog Number

11780

Brand Name

Smart Scope 1000 micrometer reusable laser fiber

Version/Model Number

SU-1000-DO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

5bb28376-1b5d-4a07-8ff0-546a5b1cec91

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 14, 2020

Package DI Number

B14511782

Quantity per Package

5

Contains DI Package

B145117800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON