Catalog Number

11070

Brand Name

272 ScopeSafe Laser Fiber for Calculase

Version/Model Number

KS-0272S-FT-000-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

35bfd074-8f58-4ab3-8416-aa2fab67c366

Public Version Date

May 26, 2021

Public Version Number

1

DI Record Publish Date

May 18, 2021

Package DI Number

00810077633328

Quantity per Package

3

Contains DI Package

00810077630327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton