FDA.reportPublic FDA data

Dragonfly®

Primary DI
B006DCKITSD52
Brand
Dragonfly®
Company
Neurovision Medical Products, Inc.
Model
N/A
Catalog number
DSPDCKIT-SD-5
Published
2023-03-20
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
DCKITSD5PackageHIBCC5In Commercial Distribution
B006DCKITSD52PrimaryHIBCC0
00810155860196SecondaryGS10
B006DCKITSD1Unit of UseHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155860196008101558601968101558601960810155860196

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic endotracheal tube electrodeA sterile electrical-conducting strip intended to be attached to an endotracheal tube to conduct the electromyographic (EMG) activity of the laryngeal and vocal cord musculature while the tube is in situ. It is used to assess the status of the nerves supplying the laryngeal musculature during surgery. It is intended to be connected to an appropriate EMG measuring/recording device, and may be supplied with a ground electrode. 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