Catalog Number

3544/A

Brand Name

SpineSTAR®

Version/Model Number

00884450296035

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K091310,K091310

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

578fff21-3411-4be8-af03-1955990d34fa

Public Version Date

May 10, 2019

Public Version Number

1

DI Record Publish Date

May 02, 2019

Package DI Number

10884450296032

Quantity per Package

75

Contains DI Package

00884450296035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-