Catalog Number

10239

Brand Name

1000 ScopeSafe Laser Fiber

Version/Model Number

OI-1000S-FT-000-BIG-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

7307c861-b8e4-4446-8515-5b137c2c7c7a

Public Version Date

April 21, 2021

Public Version Number

1

DI Record Publish Date

April 13, 2021

Package DI Number

00810077633069

Quantity per Package

3

Contains DI Package

00810077630068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton