FDA.reportPublic FDA data

Horizon™

Primary DI
10816843022331
Brand
Horizon™
Company
ROCHESTER ELECTRO-MEDICAL, INC.
Model
S94415-PT2-20
Device description
DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 1.5 M TWISTED LEADWIRE, COLOR GROUP 2
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10816843022324PackageGS120Not in Commercial Distribution
10816843022331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081684302232410816843022324
1081684302233110816843022331

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.

Contacts#

Phone, Email table
PhoneEmail
18003285544info@rochestermed.com

Regulatory Flags#

DUNS number
068156330
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816843021235Rochester2220002016-09-24
10816843021259Rochester2221112016-09-24
10816843021273Rochester2224662016-09-24
10816843020009Rochester0322382016-09-24
10816843020023Rochester0325432016-09-24
10816843020047Rochester0356872016-09-24
10816843020061Rochester0356892016-09-24
10816843020085Rochester0383752016-09-24
10816843023741Rochester2220002016-09-24
10816843023765Rochester2221112016-09-24
10816843021297Rochester2224662016-09-24
10816843020276EverLast™BMS017T15-42016-09-24
10816843020290EverLast™BMS037T15-102016-09-24
10816843020313EverLast™BMS037T15-42016-09-24
10816843020337EverLast™BMS037T15-52016-09-24
10816843020351EverLast™BMS037T15-62016-09-24
10816843020375EverLast™BMS037T15-82016-09-24
10816843020399UltraLast™BMS042T15-42016-09-24
10816843020412UltraLast™BMS042T15-52016-09-24
10816843020436UltraLast™BMS042T15-62016-09-24

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