FDA.reportPublic FDA data

NVJJB

Primary DI
00887517161307
Brand
NVJJB
Company
Nuvasive, Inc.
Model
2010040
Device description
NVJJB Electrodes, Dual Wet Gel
Published
2016-09-26
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
IKNElectromyograph, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112717000NUVASIVE NVJJB SYSTEMNuvasive, Inc.2012-04-13ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517161307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517161307008875171613078875171613070887517161307

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeA non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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
03662674000549DSG ConnectSPINEGUARDETN2026-10-22
00860010951705NeuralytixNEURALYTIX, LLCETN2026-10-19
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
04250307604388N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604388N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHGWF2026-10-01
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843908NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
00887517127693MaXcessNuvasive, Inc.ETN2026-07-27
00199874344553MEGA-TMSSoterix Medical TechnologiesGWF2026-07-10
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07