N/A

Basic Information

• Brand Name: N/A
• Primary DI: 20613994330059
• Version / Model: 945DSE0003
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-07-01
• Public Version: 5
• Public Version Date: 2019-02-06
• Public Version Status: Update
• Public Device Record Key: 1e278fb3-7f72-44c0-bfa3-7f079e1ad6c3
• Distribution End Date: 2018-10-08

Device Description

WIRE 945DSE0003 1.2M48IN RED EXT LEAD

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKN	Electromyograph, diagnostic	Physical Medicine	890.1375	2
GWS	ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL	Neurology	882.1420	1
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
IYN	System, imaging, pulsed doppler, ultrasonic	Radiology	892.1550	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE	Neurology	882.1900	2
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2
GWE	Stimulator, photic, evoked response	Neurology	882.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35723	Nerve-locating system	An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20613994330059	GS1
Unit of Use	00613994330055	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061639	000