FDA.reportPublic FDA data

NIM-Eclipse

Primary DI
00763000570262
Brand
NIM-Eclipse
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
945NCCPUE4
Device description
COMPUTER 945NCCPUE4 NOTEBOOK
Published
2022-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWFStimulator, electrical, evoked response
IYNSystem, imaging, pulsed doppler, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2
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
00763000570262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000570262007630005702627630005702620763000570262

GMDN Terms#

Term, Definition table
TermDefinition
Portable computerA portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard and/or touchscreen integrated into one unit in the form of a laptop, tablet, palmtop or other hand-held (including smartphone) device.

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
830350380
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal System39910272026-08-27
00763000704117MSB CAPSTONE CONTROL™ Spinal System39910322026-08-27
00763000704124MSB CAPSTONE CONTROL™ Spinal System39911222026-08-27
00763000704131MSB CAPSTONE CONTROL™ Spinal System39911272026-08-27
00763000704148MSB CAPSTONE CONTROL™ Spinal System39911322026-08-27
00763000704155MSB CAPSTONE CONTROL™ Spinal System39912222026-08-27
00763000704162MSB CAPSTONE CONTROL™ Spinal System39912272026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000843908NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYN2026-08-07
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYN2026-07-24
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00199874344553MEGA-TMSSoterix Medical TechnologiesGWF2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYN2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYN2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYN2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
06903053124348Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124355Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03