FDA.report

Dragonfly Laryngeal Surface Electrodes

Primary DI
18054655010685
Brand
Dragonfly Laryngeal Surface Electrodes
Company
SPES MEDICA SRL
Model
LSE3446MCA075
Published
2016-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ETNStimulator, Nerve

Product Code Classifications

CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18054655010685PrimaryGS10
08054655010688Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1805465501068518054655010685
08054655010688080546550106888054655010688

GMDN Terms

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

Regulatory Flags

DUNS number
514029771
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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08054655020793Connection cableSBM1AE0012024-05-13
08054655021707Connection cableSBM1AE0022024-05-13
08054655021714Connection cableSBM1AE0032024-05-13
08054655030037Connection cableSBM1AE0042024-05-13
18054655026815Recording and stimulating for Central Nervous System electrodesIEP00072022-11-29
18054655028222Recording and stimulating for Central Nervous System electrodesIEP00082022-11-29
18054655028239Recording and stimulating for Central Nervous System electrodesIEP00062022-11-29
18054655000402Connection cable2001PUD7126SH2021-12-22
08054655023664AC Cream - Conductive PasteACCREAM250V-32021-12-22
08054655031843SafePrepNPREP010E-12021-08-05
18054655025979Urethral Catheter ElectrodeUE0022021-05-24
18054655026013Urethral Catheter ElectrodeUE0062021-05-24
08054655031034Disposable Adhesive Surface ElectrodesTEON2F50902021-03-23
08054655031041Disposable Adhesive Surface ElectrodesTEON2F100150F2021-03-23
08054655030723IOM Stimulator ProbesSI1B0185S2526D2021-02-04
08054655010879Spes Medica Subdermal Needle ElectrodesMN2013D10S2020-08-11
08054655012897Spes Medica Pudendal ElectrodePUD00012020-03-11
18054655012399Spes Medica Subdermal Needle ElectrodesMNCS0610DS2020-01-28
18054655012474Spes Medica Subdermal Needle ElectrodesMNCS0615DS2020-01-28
18054655012528Spes Medica Subdermal Needle ElectrodesMNCS0625DS2020-01-28

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