Catalog Number

3544

Brand Name

SpineSTAR Ablation Instrument (5 10, Short)

Version/Model Number

3544

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 10, 2020

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

K091310

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

bf666d66-b9b1-4ff2-8016-a9ff58dfd76a

Public Version Date

April 13, 2020

Public Version Number

5

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-