FDA.reportPublic FDA data

SENTIO

Primary DI
10705034534787
Brand
SENTIO
Company
Medos International Sàrl
Model
286202300
Catalog number
286202300
Device description
SENTIO MMG TABLET WITH SENTIO MMG SW
Published
2018-10-08
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
ETNSTIMULATOR, NERVE
PDQNeurosurgical nerve locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173526000SENTIO MMG Gen 2Medos International SARL2018-04-05PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034534787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503453478710705034534787

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-function monitorA mains electricity (AC-powered) bedside device designed to continuously assess the adequacy of the nerve function of a non-ambulatory patient who requires monitoring (e.g., as a result of trauma, anaesthesia, intervention, evaluation). It typically monitors evoked potential (EP), electromyography (EMG), electroencephalography (EEG) and/or neuromuscular block response. It typically consists of electrodes applied to the patient intended to acquire the neural electrical signal, and a computerized unit to process and display the information; stimulation systems for nerve block and evoked potential evaluation are separate requirements.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647807TRIALTIS5161-00-514551610051452026-06-03
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22
10886705030293NA2426542426542018-02-22
10705034606897TRIALTIS5560886545S5560886545S2026-05-29
10705034608679TRIALTIS5560520004S5560520004S2026-05-29

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Primary DI, Brand, Company table
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08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
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20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
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20763000842561Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
08720791376451Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
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10705034604527TELIGENMedos International SàrlPDQ2024-02-10
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B006LTE7003PMD52Cobra®Neurovision Medical Products, Inc.ETN2023-04-06
B006LTE7003PSD52Cobra®Neurovision Medical Products, Inc.ETN2023-04-06
B006NVFKITD52Nerveana®Neurovision Medical Products, Inc.ETN2023-04-06
B006NVFKITNPD52Nerveana®Neurovision Medical Products, Inc.ETN2023-04-06