VIVA RF Electrode 15-15V05-30X

GUDID 28809306761389

The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.

STARMED CO.,LTD

Percutaneous electrosurgical probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

• Primary Device ID: 28809306761389
• NIH Device Record Key: 94072a67-f420-48ce-b0bb-964a29b5b30a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVA RF Electrode
• Version Model Number: 15-15V05-30X
• Catalog Number: 15-15V05-30X
• Company DUNS: 694699723
• Company Name: STARMED CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com
• Phone: +82318163546
• Email: inquiry@starmed4u.com

Device Dimensions

• Needle Gauge: 15 Gauge
• Length: 15 Centimeter
• Needle Gauge: 15 Gauge
• Length: 15 Centimeter
• Needle Gauge: 15 Gauge
• Length: 15 Centimeter
• Needle Gauge: 15 Gauge
• Length: 15 Centimeter
• Needle Gauge: 15 Gauge
• Length: 15 Centimeter
• Needle Gauge: 15 Gauge
• Length: 15 Centimeter
• Needle Gauge: 15 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809306761385 [Primary]
GS1	18809306761382 [Package]; Contains: 08809306761385; Package: Carton [5 Units]; In Commercial Distribution
GS1	28809306761389 [Package]; Contains: 08809306761385; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172012

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-03-21

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