Catalog Number

101258-IC

Brand Name

Twister

Version/Model Number

101258-IC

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

K112987

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

b5a12994-2b34-4875-b980-ed6b10aaf45b

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-