FDA.reportPublic FDA data

NA

Primary DI
00643169553040
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
945EEX901LO
Device description
STIMULATOR 945EEX901LO LOANER EXTENDER
Published
2016-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
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
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
00643169553040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169553040006431695530406431695530400643169553040

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system, line-poweredAn assembly of mains electricity (AC-powered) devices designed to locate a nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
1
Serial number
true

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00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
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00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15

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