FDA.report

Rhythmlink®

Primary DI
00816312022575
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
BNT110-STD-5462
Device description
17 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector and 1 template, color-coded original BraiNet
Published
2016-09-17
Public version status
Update
Distribution status
Not 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
00816312022575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816312022575008163120225758163120225750816312022575

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
8666333754xx@xx.xx

Regulatory Flags

DUNS number
126290993
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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10816312027850Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-12-05
10816312027867Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-12-03
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00816312027372Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-07-30
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