FDA.report

Horizon™

Primary DI
00849593008976
Brand
Horizon™
Company
AMC
Model
NS-S83025-PL1-20
Device description
DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.5 M PARALLEL LEADWIRE, COLOR GROUP 1 - 20 PAIRS/BOX
Published
2018-07-11
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

Related Records

Contact Domains

Product Codes

CodeName
GXZElectrode, Needle

Product Code Classifications

CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849593008976PrimaryGS10
00849593008969Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593008976008495930089768495930089760849593008976
00849593008969008495930089698495930089690849593008969

GMDN Terms

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

Contacts

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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08720791377700InomedTechnomed Engineering B.V.GXZ2025-12-10
10816312027850Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-12-05
10816312027867Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-12-03
00816312027365Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-07-30
00816312027372Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-07-30
08720791377656CadwellTechnomed Engineering B.V.GXZ2025-05-26
08720791377670CadwellTechnomed Engineering B.V.GXZ2025-05-26
00816312027709Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027716Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027723Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027730Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027747Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
10816312027652Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10816312027669Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10841019116910KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-07
10841019122409KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
10841019122416KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
10841019122423KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
08720791374587NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374600NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374624NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374648NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374662NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374686NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791375706CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375720CadwellTechnomed Engineering B.V.GXZ2025-02-28
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