FDA.report

Rhythmlink®

Primary DI
10816312022015
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
MRDC410
Device description
12 - 10mm, Ag/AgCl cup with 9 inch leadwire
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10816312022015PrimaryGS10
00816312022018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631202201510816312022015
00816312022018008163120220188163120220180816312022018

GMDN Terms

TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
8666333754xx@xx.xx

Regulatory Flags

DUNS number
126290993
Device count
12
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
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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10816312027867Rhythmlink®CTGN2121-2.52025-12-03
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10816312027805Rhythmlink®MRQSWB20908152025-09-24
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00816312027372Rhythmlink®GNFD51522025-07-30
00816312027785Rhythmlink®CTDC2615202025-07-24
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00816312027723Rhythmlink®RLSP5542025-05-16
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00816312027747Rhythmlink®RLSP5562025-05-16
10816312027652Rhythmlink®RLSND801-2.52025-05-05
10816312027669Rhythmlink®RLSND802-2.52025-05-05
10816312027690Rhythmlink®MRQDW106302025-04-21

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