FDA.reportPublic FDA data

PULSE

Primary DI
00887517939838
Brand
PULSE
Company
Nuvasive, Inc.
Model
1840161
Device description
PULSE SSEP Surface Electrodes
Published
2018-06-26
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
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE
HAWNeurological stereotaxic Instrument
IKNElectromyograph, diagnostic
OLOOrthopedic stereotaxic instrument
PDQNeurosurgical nerve locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2
HAWNeurological Stereotaxic InstrumentNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
OLOOrthopedic Stereotaxic InstrumentNeurology2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162313000NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated2017-03-16PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517939838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517939838008875179398388875179398380887517939838

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

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517614360Propel50200012015-09-24
00887517614377Propel50200052015-09-24
00887517614384Propel50200102015-09-24
00887517939951AttraX50151102018-06-05
00887517939968AttraX50151202018-06-05
00887517939975AttraX50151302018-06-05
00887517939982AttraX50151032018-06-05
00887517939999AttraX50151042018-06-05
00887517940001AttraX50151062018-06-05
00887517940018AttraX50151012018-06-05
00887517940025AttraX50151022018-06-05
00887517970435Propel50202052018-12-20
00887517970442Propel50202059942018-12-20
00887517970459Propel50202102018-12-20
00887517970466Propel50202109942018-12-20
00887517970473Propel50203012018-12-20
00887517970480Propel50203019942018-12-20
00887517970497Propel50203052018-12-20
00887517971500Propel50203059942018-12-20
00887517971517Propel50203102018-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010951705NeuralytixNEURALYTIX, LLCETN2026-10-19
00860010951705NeuralytixNEURALYTIX, LLCPDQ2026-10-19
04056481147969Spine and Trauma NavigationBrainlab SEOLO2026-10-19
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
00810161901562EARP NERVE CUFF ELECTRODE, 5MMRETROPSOAS TECHNOLOGIES, LLCETN2026-10-16
00810161901548EARP NERVE CUFF ELECTRODE, 3MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901555EARP NERVE CUFF ELECTRODE, 4MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901579EARP NERVE CUFF ELECTRODE, 6MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00889024713390ROSA® ShoulderOrthosoft IncOLO2026-10-15
00885556919781Real IntelligenceSmith & Nephew, Inc.OLO2026-10-13
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
04056481144906Spine &Trauma NavigationBrainlab SEOLO2024-11-14
04056481144753Drill Guide ArrayBrainlab SEOLO2024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)Brainlab SEOLO2024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)Brainlab SEOLO2024-06-04
04056481144784Drill Guide Tube (4.5 mm)Brainlab SEOLO2024-06-04
04056481144791Drill Guide Tube (3.2 mm)Brainlab SEOLO2024-06-04
04056481144807Drill Guide Tube (2.6 mm)Brainlab SEOLO2024-06-04
04056481144814Drill Guide Tube (2.4 mm)Brainlab SEOLO2024-06-04
04056481144821Drill Guide Tube (2.0 mm)Brainlab SEOLO2024-06-04
04056481144838Drill Guide HandleBrainlab SEOLO2024-06-04
04056481145057Drill Guide Trocar Insert (2.0 mm)Brainlab SEOLO2024-06-04
04056481145064Drill Guide Trocar Insert (2.4 mm)Brainlab SEOLO2024-06-04
04056481145071Drill Guide Trocar Insert (2.6 mm)Brainlab SEOLO2024-06-04
04056481145088Drill Guide Trocar Insert (3.2 mm)Brainlab SEOLO2024-06-04
04056481145095Drill Guide Trocar Insert (4.5 mm)Brainlab SEOLO2024-06-04
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)Brainlab SEOLO2023-10-17
00887868579219OptiVu™ Mixed RealityOrthosoft IncOLO2023-09-07