Silverstein Facial Nerve Stimulator

Basic Information

• Brand Name: Silverstein Facial Nerve Stimulator
• Primary DI: 00702173139104
• Version / Model: S8
• Company Name: WR MEDICAL ELECTRONICS CO INC
• Labeler DUNS: 006196604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-29
• Public Version: 3
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: f0166f5c-945a-4c89-9249-24a1e974160a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETN	Stimulator, Nerve	Ear, Nose, Throat	874.1820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35724	Facial nerve-locating system	An assembly of devices designed to locate a facial nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. It typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge, electrical sensors), and audible and/or visual indicators. The system generates rectangular- and possibly triangular-waveform currents to stimulate nerve fibres and produce muscular contraction. It is used during diagnosis and assessment of nerve function, to locate nerves during surgery reducing the chance of accidental injury, and to monitor the progress of nerve regeneration after surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00702173139104	GS1

Customer Contacts

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