FDA.reportPublic FDA data

NIM-ECLIPSE®

Primary DI
00643169553071
Brand
NIM-ECLIPSE®
Company
MEDTRONIC XOMED, INC.
Model
945NCCPULO
Device description
COMPUTER 945NCCPULO LOANER NOTEBOOK
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
K050798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050798000ECLIPSE NEUROLOGICAL WORKSTATIONAxon Systems, Inc.2005-08-15GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169553071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169553071006431695530716431695530710643169553071

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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00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
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00643169782617NIM Trivantage®82297092016-11-12
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Primary DI, Brand, Company table
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00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYN2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
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04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYN2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
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08056304453525MyLabX7ESAOTE SPAITX2019-06-13
08056304453563MyLabX5ESAOTE SPAITX2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYN2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYN2019-06-13
08056304453921MyLab 9ESAOTE SPAITX2019-06-13
08033928120897MicromedMICROMED SPAGWQ2018-05-21
08033928120903MicromedMICROMED SPAGWQ2018-05-21
08033928120958MicromedMICROMED SPAGWE2018-05-21
08033928120958MicromedMICROMED SPAGWQ2018-05-21
08033928120958MicromedMICROMED SPAGWF2018-05-21
08033928120880micromedMICROMED SPAGWF2018-03-21