Simplicity™ RFDE-SI

GUDID 05415067021564

Disposable Radiofrequency Electrode

NEUROTHERM, INC.

Percutaneous electrosurgical probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

• Primary Device ID: 05415067021564
• NIH Device Record Key: 7adc3d0f-b564-4918-99fd-ea0ddb3d764b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplicity™
• Version Model Number: III
• Catalog Number: RFDE-SI
• Company DUNS: 124023552
• Company Name: NEUROTHERM, INC.
• 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: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place; avoid exposure to extreme temperatures.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067021564 [Primary]

FDA Product Code

• GXI: PROBE, RADIOFREQUENCY LESION

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: 2018-11-08
• Device Publish Date: 2016-05-10

Devices Manufactured by NEUROTHERM, INC.

• 05415067021564 - Simplicity™: 2018-11-08Disposable Radiofrequency Electrode
• 05415067021564 - Simplicity™: 2018-11-08 Disposable Radiofrequency Electrode
• 15415067021615 - NeuroTherm™: 2018-11-08 Disposable Radiofrequency Electrode
• 15415067022315 - NeuroTherm™: 2018-11-08 Disposable Radiofrequency Electrode
• 05415067026576 - NeuroTherm™: 2018-11-08 PodiaTherm Disposable Kit
• 05415067021243 - NeuroTherm™: 2018-05-08
• 05415067021250 - NeuroTherm™: 2018-05-08
• 05415067021298 - NeuroTherm™: 2018-05-08
• 05415067021328 - NeuroTherm™: 2018-05-08