Catalog Number

10367

Brand Name

272 ScopeSafe Laser Fiber

Version/Model Number

KS-272S-FT-000-BLU-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

cfe657b4-39eb-4be4-b602-9cd3d516b858

Public Version Date

May 19, 2021

Public Version Number

1

DI Record Publish Date

May 11, 2021

Package DI Number

00810077633090

Quantity per Package

3

Contains DI Package

00810077630099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton