star RF Electrode - The star RF Electrode is a sterile, single-use - STARMED CO.,LTD

Duns Number:694699723

Device Description: The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be us The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.

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More Product Details

Catalog Number

-

Brand Name

star RF Electrode

Version/Model Number

18-10s04F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

5ebd387f-6f0b-4aa2-b231-740df5e34a3d

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 09, 2021

Additional Identifiers

Package DI Number

18809306763669

Quantity per Package

5

Contains DI Package

08809306763662

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"STARMED CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8