FDA.reportPublic FDA data

Alpine BioMed

Primary DI
05704736018494
Brand
Alpine BioMed
Company
Alpine Biomed ApS
Model
9031C0881
Device description
MER AMPLIFIER FOR LEADPOINT FOCUS
Published
2016-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140680000LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEMAlpine Biomed Aps2014-12-12GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05704736018494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05704736018494057047360184945704736018494

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
311231554
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05704736000284Alpine Biomed9013C05322016-10-13
05704736000680Alpine Biomed 9030L10322016-10-13
05704736001793Alpine BioMed9031A0065AA2016-08-23
05704736001809Alpine BioMed9031A0065HA2016-08-23
05704736001823Alpine BioMed9031A0065022016-08-23
05704736001830Alpine BioMed9031A0065032016-08-23
05704736001847Alpine BioMed9031A0065042016-08-23
05704736001854Alpine BioMed9031A0065052016-08-23
05704736001861Alpine BioMed9031A0065062016-08-23
05704736002288Alpine BioMed9031C05032016-08-23
05704736002363Alpine BioMed9031E01532016-08-23
05704736002387Alpine Biomed 9031E02232016-10-13
05704736002394Alpine Biomed9031E02582016-10-13
05704736002400Alpine Biomed9031E02682016-10-13
05704736002417Alpine Biomed9031E02772016-10-13
05704736002431Alpine Biomed 9031E04022016-10-13
05704736002592Alpine BioMed9031D03032016-08-24
05704736006712Alpine Biomed9080D10942016-10-13
05704736007320Alpine BioMed9031G01862016-08-24
05704736008716Alpine BioMed9031A0701AA2016-08-23

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Primary DI, Brand, Company table
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