FDA.reportPublic FDA data

Hilger Dual Stim

Primary DI
00702173139005
Brand
Hilger Dual Stim
Company
WR MEDICAL ELECTRONICS CO INC
Model
3900
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063560000HILGER DUAL-STIM NERVE STIMULATORWr Medical Electronics Co.2007-01-05ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00702173139005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00702173139005007021731390057021731390050702173139005

GMDN Terms#

Term, Definition table
TermDefinition
Facial nerve locating systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-604-8400info@wrmed.com

Regulatory Flags#

DUNS number
006196604
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00702173456508HRV Acquire56502016-07-25
00702173131870Surgical Probe Monopolar31872016-08-29
00702173131887Surgical Probe, Monopolar w/Protected Plug31882016-08-29
00702173132174Silverstein Facial Nerve Stimulator Remote Probe32172016-08-29
00702173139050Hilger Dual-Stimulator Remote Probe39052016-08-29
00702173139104Silverstein Facial Nerve StimulatorS82016-08-29
00702173122755TherabathTB92020-03-11
00702173122809TherabathTB102019-11-06
00702173151885Q-Sweat51882016-09-12
00702173151915Meridian™ Iontophoretic Drug Delivery Electrode51912016-09-12
00702173152929Meridian™ Iontophoretic Drug Delivery Electrode52922017-06-06
00702173155920Iontophor®-II6111PM/DX2017-02-21
00702173355696CASEIV2016-08-29
00702173123202TherabathTB62016-08-29
00702173123226TherabathTB72016-08-29

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10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
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B006NVPTKITDCLD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
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