NeuroTherm™ SMK-S1010-20

GUDID 15415067021820

Radiofrequency Cannula - Straight

NEUROTHERM, INC.

Radio-frequency ablation system probe cannula, single-use

• Primary Device ID: 15415067021820
• NIH Device Record Key: 15d12d74-8958-4368-8f01-f156e362930d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroTherm™
• Version Model Number: SMK
• Catalog Number: SMK-S1010-20
• 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
• 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: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter
• Needle Gauge: 20 Gauge
• Length: 10 Centimeter

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.
• 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	05415067021823 [Primary]
GS1	15415067021820 [Package]; Contains: 05415067021823; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042375

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: 2016-03-23

On-Brand Devices [NeuroTherm™]

• 05415067026576: PodiaTherm Disposable Kit
• 05415067023629: RF-DGP-S
• 05415067023612: Grounding Pad
• 15415067022926: Radiofrequency Cannula-Curved Blunt
• 15415067022919: SL
• 15415067022452: CLASSIC
• 15415067022445: CLASSIC
• 15415067022438: CLASSIC
• 15415067022407: CLASSIC
• 15415067022391: RFDEUK-5
• 15415067022360: RFDEUK-20
• 15415067022346: RFDEUK-15
• 15415067022315: Disposable Radiofrequency Electrode
• 15415067022292: CLASSIC
• 15415067022285: CLASSIC
• 15415067022261: CLASSIC
• 15415067022247: Radiofrequency Cannula - Straight
• 15415067022230: CLASSIC
• 15415067022193: CLASSIC
• 15415067022179: CLASSIC
• 15415067022155: CLASSIC
• 15415067022131: CLASSIC
• 15415067022124: CLASSIC
• 15415067022117: CLASSIC
• 15415067022100: CLASSIC
• 15415067022094: CLASSIC
• 15415067022087: CLASSIC
• 15415067022070: CLASSIC
• 15415067022063: CLASSIC
• 15415067022056: CLASSIC
• 15415067022049: CLASSIC
• 15415067022032: CLASSIC
• 15415067022025: CLASSIC
• 15415067022018: CLASSIC
• 15415067022001: CLASSIC
• 15415067021998: CLASSIC
• 15415067021981: CLASSIC
• 15415067021974: CLASSIC
• 15415067021967: CLASSIC
• 15415067021950: CLASSIC
• 15415067021943: CLASSIC
• 15415067021936: CLASSIC
• 15415067021929: CLASSIC
• 15415067021912: Radiofrequency Cannula - Curved
• 15415067021905: Radiofrequency Cannula - Curved
• 15415067021899: Radiofrequency Cannula - Curved
• 15415067021882: Radiofrequency Cannula - Curved
• 15415067021875: Radiofrequency Cannula - Curved
• 15415067021868: Radiofrequency Cannula - Straight
• 15415067021851: Radiofrequency Cannula - Straight