NeuroTherm™ S-1010-18

GUDID 15415067022216

NEUROTHERM, INC.

Radio-frequency ablation system probe cannula, single-use

• Primary Device ID: 15415067022216
• NIH Device Record Key: d2d2a920-f65f-4aa1-85e6-407b96a3fe59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroTherm™
• Version Model Number: CLASSIC
• Catalog Number: S-1010-18
• 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

Device Dimensions

• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge

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	05415067022219 [Primary]
GS1	15415067022216 [Package]; Contains: 05415067022219; Package: [10 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-14

On-Brand Devices [NeuroTherm™ ]

• 15415067022940: CLASSIC
• 15415067022933: CLASSIC
• 15415067022216: CLASSIC