NeuroTherm™ SMK-S1505-20

GUDID 15415067021844

Radiofrequency Cannula - Straight

NEUROTHERM, INC.

Radio-frequency ablation system probe cannula, single-use

Primary Device ID	15415067021844
NIH Device Record Key	88113f7f-f488-49b8-8b69-ec795ee266ba
Commercial Distribution Status	In Commercial Distribution
Brand Name	NeuroTherm™
Version Model Number	SMK
Catalog Number	SMK-S1505-20
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

Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge
Length	15 Centimeter
Needle Gauge	20 Gauge

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place. Avoid exposure to extreme temperatures. Do not use if package is damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067021847 [Primary]
GS1	15415067021844 [Package] Contains: 05415067021847 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	2016-05-10

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

Trademark Results [NeuroTherm]

Mark Image Registration \| Serial	Company Trademark Application Date
NEUROTHERM 76063816 2575296 Live/Registered	NEUROTHERM INC. 2000-06-06