FDA.reportPublic FDA data

N/A

Primary DI
20613994330059
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
945DSE0003
Device description
WIRE 945DSE0003 1.2M48IN RED EXT LEAD
Published
2016-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWEStimulator, photic, evoked response
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE
GWJSTIMULATOR, AUDITORY, EVOKED RESPONSE
GWQFull-montage Standard Electroencephalograph
GWSANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL
IKNElectromyograph, diagnostic
ITXTransducer, ultrasonic, diagnostic
IYNSystem, imaging, pulsed doppler, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
GWSAnalyzer, Spectrum, Electroencephalogram SignalNeurology1
IKNElectromyograph, DiagnosticPhysical Medicine2
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061639000ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMONAxon Systems, Inc.2006-11-01GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994330059PrimaryGS10
00613994330055Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399433005920613994330059
00613994330055006139943300556139943300550613994330055

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating systemAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
10
Lot or batch
true
Sterilization required before use
true

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00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24

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Primary DI, Brand, Company table
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08056304453525MyLabX7ESAOTE SPAITX2019-06-13
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08033928120897MicromedMICROMED SPAGWQ2018-05-21
08033928120903MicromedMICROMED SPAGWQ2018-05-21
08033928120958MicromedMICROMED SPAGWE2018-05-21
08033928120958MicromedMICROMED SPAGWQ2018-05-21
08033928120958MicromedMICROMED SPAGWF2018-05-21
08033928120880micromedMICROMED SPAGWQ2018-03-21
08033928120880micromedMICROMED SPAGWF2018-03-21