FDA.reportPublic FDA data

Dragonfly®

Primary DI
B006SCKITM52
Brand
Dragonfly®
Company
Neurovision Medical Products, Inc.
Model
N/A
Catalog number
DSPSCKIT-M-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
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
SCKITM5PackageHIBCC5In Commercial Distribution
B006SCKITM52PrimaryHIBCC0
00810155862190SecondaryGS10
B006SCKITM1Unit of UseHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155862190008101558621908101558621900810155862190

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
08718375866061Neurosign V4Technomed Engineering B.V.ETN2022-07-04
08718375869062AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869093AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869123AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375868102Consolidated Neuro SupplyTechnomed Engineering B.V.IKT2021-06-02
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
08718375867556Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867570Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867884Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867891Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867907Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867914Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867921Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867938Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867969Neurosign V4Technomed Engineering B.V.IKT2021-01-12
08718375867983Neurosign V4Technomed Engineering B.V.IKT2021-01-12
08718375867327Technomed EuropeTechnomed Engineering B.V.IKT2020-12-08
08718375867341Technomed EuropeTechnomed Engineering B.V.IKT2020-12-08
08718375867365Technomed EuropeTechnomed Engineering B.V.IKT2020-12-08
08718375861707Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21
08718375866788Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21