FDA.reportPublic FDA data

Horizon™

Primary DI
00849593008778
Brand
Horizon™
Company
AMC
Model
NS-S94425-PT1-20
Device description
DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 2.5 M TWISTED LEADWIRE, COLOR GROUP 1 - 20/Box
Published
2018-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849593008778PrimaryGS10
00849593008761Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593008778008495930087788495930087780849593008778
00849593008761008495930087618495930087610849593008761

GMDN Terms#

Term, Definition table
TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-345-9800info@advantagemed.com

Regulatory Flags#

DUNS number
080242300
Device count
20
DM exempt
true
Premarket exempt
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849593025133GoldSelect™DE-0037602023-01-30
20849593005344LifeSyncLS-238B2022-11-21
00084959302521GoldSelect™DGE-602022-11-18
00849593005746LifeSyncLS-2282022-11-20
20849593005764LifeSyncLS-2292022-11-20
00849593005784LifeSyncLS-228D2022-11-20
20849593005801LifeSyncLS-229D2022-11-20
00849593025140GoldSelect™DE-0037602022-11-20
00849593025157GoldSelect™DE-0037102022-11-20
00849593025164GoldSelect™DE-003748-252022-11-20
00849593025171GoldSelect™DE-003760-252022-11-20
00849593025188GoldSelect™DE-003772-252022-11-20
00849593025195GoldSelect™DE-003748-VA2022-11-18
00849593025201GoldSelect™DGE-482022-11-18
00849593025225GoldSelect™DGE-722022-11-18
00849593025232GoldSelect™DGE-1202022-11-18
00849593025249GoldSelect™DE-0037482022-11-18
00849593004138AMCCB-73331R2022-10-17
00849593031998AMCLW-3090024/5A2022-10-17
00849593025041LifeSyncAB 1000 (S)CB-AB 1000-0 (S)2022-10-03

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Primary DI, Brand, Company table
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08720791377656CadwellTechnomed Engineering B.V.GXZ2025-05-26
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00816312027709Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
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08720791374587NeurosignTechnomed Engineering B.V.GXZ2025-02-28
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08720791375706CadwellTechnomed Engineering B.V.GXZ2025-02-28
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08720791375744CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375768CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375782CadwellTechnomed Engineering B.V.GXZ2025-02-28
10816312027515Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-02-26