FDA.reportPublic FDA data

NONE

Primary DI
B006IDKMCF512B52
Brand
NONE
Company
Neurovision Medical Products, Inc.
Model
NONE
Catalog number
DSPI-DK-MCF512B-5
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091410000DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,Spes Medica Srl2009-08-11IKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B006IDKMCF512B52PrimaryHIBCC0
00810155860561SecondaryGS10
B006IDKMCF512B1Unit of UseHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155860561008101558605618101558605610810155860561

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
182057401
Device count
5
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810155862589NONENONEDSPRLNKIT-LT-52025-12-19
00810155862602NONENONEDSPRLNKIT-MT-52025-12-19
00810155862626NONENONEDSPRLNKIT-ST-52025-12-19
00810155862640NONENONEDSPRLNKIT-L-52025-12-19
00810155862664NONE NONEDSPRLNKIT-M-52025-12-19
00810155862688NONENONEDSPRLNKIT-S-52025-12-19
B006NVHS102NONENONEDSPRLNKIT-M-52025-12-18
B006NVHS1021NONENONEDSPRLNKIT-M-52025-12-18
B006IDKATF714B52ScorpionN/ADSPI-DK-ATF714B-52021-11-17
B006IDKMF512B52ScorpionN/ADSPI-DK-MF512B-52021-11-17
B006IDKWSF51252ScorpionN/ADSPI-DK-WSF512-52023-09-01
B006LTE7003PL52CobraN/ADSPLTE7003PL-52020-08-12
B006LTE7003PLD52Cobra®N/ADSPLTE7003PLD-52023-03-20
B006LTE7003PLT52CobraN/ADSPLTE7003PLT-52020-08-12
B006LTE7003PM52CobraN/ADSPLTE7003PM-52020-08-12
B006LTE7003PMD52Cobra®N/ADSPLTE7003PMD-52023-04-06
B006LTE7003PMT52CobraN/ADSPLTE7003PMT-52020-08-12
B006IDKSHEMM52NONENONEDSPI-DK-SHEM-M-52016-09-24
B006IJRF714B0NONENONEREUI-JRF714B2016-09-24
B006IJRF714BL0NONENONEREUI-JRF714B-L2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720791375140NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
08718375866061Neurosign V4Technomed Engineering B.V.ETN2022-07-04
08718375867129NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867143NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867167NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867181NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867204NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867228NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867242NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867266NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867280NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867303NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867327Technomed EuropeTechnomed Engineering B.V.IKT2020-12-08
08718375867341Technomed EuropeTechnomed Engineering B.V.IKT2020-12-08
08718375867365Technomed EuropeTechnomed Engineering B.V.IKT2020-12-08
04250307609949N/Ainomed Medizintechnik GmbHETN2019-12-17
04250307610075N/Ainomed Medizintechnik GmbHETN2019-12-17
04250307610105N/Ainomed Medizintechnik GmbHETN2019-12-17
04250307610167N/Ainomed Medizintechnik GmbHETN2019-12-17
04250307610181N/Ainomed Medizintechnik GmbHETN2019-12-17
04250307610198N/Ainomed Medizintechnik GmbHETN2019-12-17
08718375861707Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21
08718375866788Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21