Catalog Number

11098

Brand Name

300 Flex-G Laser Fiber with Sheath for Calculase

Version/Model Number

KS-0300S-FT-SC0-LEX-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

c145ba77-9445-46ba-b346-903155f9c5bd

Public Version Date

May 26, 2021

Public Version Number

1

DI Record Publish Date

May 18, 2021

Package DI Number

00810077633380

Quantity per Package

3

Contains DI Package

00810077630389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton