FDA.reportPublic FDA data

N/A

Primary DI
00613994513960
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
945MNP2001
Device description
PROBE 945MNP2001 100MM DIRECT NERVE
Published
2016-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K090838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090838000STIMULUS/DISSECTION INSTRUMENTSAxon Systems, Inc.2009-07-20ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994513960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994513960006139945139606139945139600613994513960

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.

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150077359Medtronic Reusable InstrumentsEX02260492026-06-01
00199150077366Medtronic Reusable InstrumentsEX02260512026-06-01
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy System43612552026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy System43612202026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy System43613082026-06-01
00763000881252Clydesdale™ Spinal System49860402026-05-29
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
B006NVHS102NONENeurovision Medical Products, Inc.ETN2025-12-18
B006HGELS102NONENeurovision Medical Products, Inc.ETN2025-02-12
B006NVPS2Nerveäna+®Neurovision Medical Products, Inc.ETN2025-02-11
20763000842547Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842554Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842561Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
08720791376451Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376475Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376482Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791373634NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
08720791373665NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCLWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSD52Nerveana+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPTKITDCSWF52Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPMK1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPSTST2Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPT1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPUSB1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006IDKWSF51252ScorpionNeurovision Medical Products, Inc.ETN2023-09-01
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.ETN2023-04-20