Catalog Number

101220

Brand Name

Twister™ Side-Fire Fiber Optic Delivery System

Version/Model Number

Twister™ L

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

9c2fde4a-5cf5-4d7a-83d9-2c00f67f577a

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

January 31, 2017

Package DI Number

04049089300188

Quantity per Package

5

Contains DI Package

04049089200181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box