FDA.reportPublic FDA data

Dragonfly®

Primary DI
B006SCKITMT52
Brand
Dragonfly®
Company
Neurovision Medical Products, Inc.
Model
N/A
Catalog number
DSPSCKIT-MT-5
Published
2023-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GXZElectrode, NeedleNeurology2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
SCKITMT5PackageHIBCC5In Commercial Distribution
B006SCKITMT52PrimaryHIBCC0
00810155862299SecondaryGS10
B006SCKITMT1Unit of UseHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155862299008101558622998101558622990810155862299

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system probe, single-useA hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.

Regulatory Flags#

DUNS number
182057401
Device count
5
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
B006IDKMCF512B52NONENONEDSPI-DK-MCF512B-52016-09-24
B006IDKSHEMM52NONENONEDSPI-DK-SHEM-M-52016-09-24
B006IJRF714B0NONENONEREUI-JRF714B2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08718375861707Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08718375861707Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21
08033315122299BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122312BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122336BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122350BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122374BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122398BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122411BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122442BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122466BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122541BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122565BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122589BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122602BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122626BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122640BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122664BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122688BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
07613327292176NAStryker Leibinger GmbH & Co. KGETN2016-12-22
07613327292183NAStryker Leibinger GmbH & Co. KGETN2016-12-22
07613327292206NAStryker Leibinger GmbH & Co. KGETN2016-12-22
07613327292220NAStryker Leibinger GmbH & Co. KGETN2016-12-22
07613327003406ES2 SPINAL SYSTEMStryker CorporationETN2016-09-24
08718375861714Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861721Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861738Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861745Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861752Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861769Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22