FDA.report

Neurosign Lantern Laryngeal Electrode 6/7mm

Primary DI
15060229531398
Brand
Neurosign Lantern Laryngeal Electrode 6/7mm
Company
THE MAGSTIM COMPANY LIMITED
Model
4201-00
Device description
To fit 6 or 7mm endotracheal tubes
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ETNStimulator, Nerve

Product Code Classifications

CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15060229531398PackageGS110In Commercial Distribution
05060229531391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1506022953139815060229531398
05060229531391050602295313915060229531391

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+441994241111salesoperations@magstim.com

Regulatory Flags

DUNS number
500375274
Device count
1
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
true
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

Primary DIBrandModelCatalogPublished
05060229531476Magstim Plus1 Module4040-002025-07-10
05060229531513Magstim D70 Alpha Coil4150-002025-07-10
05060229531520Magstim D70 Alpha Flat Coil (Coated)4170-002025-07-10
05060229531803Magstim D60 Alpha Flat Coil (Coated)4190-002025-07-10
05060229531926Magstim Plus1 Module 115V4040-US2025-07-10
05060229531964Magstim D60α Branding Iron (Coated) Coil4189-002025-07-10
05060229531971Magstim D70α Branding Iron (Coated) Coil4510-002025-07-10
05060229530868Magstim Double 70mm Air Film Coil3950-002025-02-19
05060229532411D25 Alpha B.I. Coil5220-002025-02-19
05060229533012Horizon 3.0 Coil Holder5835-00-502025-02-19
05060229533029Horizon 3.0 Camera Stand5471-00-502025-02-19
05060229533074Horizon 3.0 MEP Pod6261-002024-10-30
05060229533081Horizon 3.0 Inspire Mainframe6251-002024-10-30
05060229533005Horizon 3.0 Interface Unit 5445-00-502024-05-09
05060229533036Horizon 3.0 ez Cool Coil 5620-00-502024-05-09
05060229532107D70 Alpha Sham Coil4334-002024-03-11
05060229532923StimGuide Pro Pointer Tool6438-002024-01-01
05060229532930StimGuide Pro Head Reference5968-002024-01-01
05060229532947StimGuide Pro MT Coil Tracker Tool5967-012024-01-01
05060229532954StimGuide Pro E-z Coil Tracker Tool5966-102024-01-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10860013827103Evala nerve stimulatorEpineuron Technologies Inc.ETN2026-03-17
00199150023851N/AMEDTRONIC XOMED, INC.ETN2026-02-16
00199150023868N/AMEDTRONIC XOMED, INC.ETN2026-02-16
00199150023875N/AMEDTRONIC XOMED, INC.ETN2026-02-16
00199150023882N/AMEDTRONIC XOMED, INC.ETN2026-02-16
00840067103029ZenithCADWELL INDUSTRIES, INC.ETN2025-12-31
00810155862664NONE Neurovision Medical Products, Inc.ETN2025-12-19
00810155862688NONENeurovision Medical Products, Inc.ETN2025-12-19
08720791377717InomedTechnomed Engineering B.V.ETN2025-12-10
08720791377724InomedTechnomed Engineering B.V.ETN2025-12-10
08720791377731InomedTechnomed Engineering B.V.ETN2025-12-10
00643169547087NIM®MEDTRONIC XOMED, INC.ETN2025-09-13
00763000831479NIM™MEDTRONIC XOMED, INC.ETN2025-08-11
20763000831480NIM™MEDTRONIC XOMED, INC.ETN2025-08-11
20763000831497NIM™MEDTRONIC XOMED, INC.ETN2025-08-11
14250307612076N/Ainomed Medizintechnik GmbHETN2025-05-02
14250307612083N/Ainomed Medizintechnik GmbHETN2025-05-02
00816312027570Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCETN2025-03-21
B066HGELS1NONENEUROVISION MEDICAL PRODUCTS, INC.ETN2025-02-12
B006IJCBFB60NONENEUROVISION MEDICAL PRODUCTS, INC.ETN2025-02-12
00763000835330NIM NeuroMEDTRONIC XOMED, INC.ETN2025-01-23
00190376530024SafeOp 3ALPHATEC SPINE, INC.ETN2024-11-12
00763000842543Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
00763000842550Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
00763000842567Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
00763000891862ENT NIM ElectrodeMEDTRONIC XOMED, INC.ETN2024-09-23
00763000891879ENT NIM ElectrodeMEDTRONIC XOMED, INC.ETN2024-09-23
00763000580483ENT NIM VitalMEDTRONIC XOMED, INC.ETN2024-09-19
00763000576769N/AMEDTRONIC XOMED, INC.ETN2024-09-14
00763000576776N/AMEDTRONIC XOMED, INC.ETN2024-09-14