FDA.report

Rhythmlink®

Primary DI
00816312023701
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
DAGDWEBB2415
Device description
Disposable Slim EEG Cup Electrodes and Webb EEG Electrodes
Published
2019-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00816312023701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816312023701008163120237018163120237010816312023701

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
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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10816312027867Rhythmlink®CTGN2121-2.52025-12-03
00816312027792Rhythmlink®MRSWB14152025-09-29
10816312027805Rhythmlink®MRQSWB20908152025-09-24
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00816312027785Rhythmlink®CTDC2615202025-07-24
00816312027761Rhythmlink®DC21152025-07-23
00816312027778Rhythmlink®DC271522025-07-23
00816312027709Rhythmlink®RLSP5522025-05-16
00816312027716Rhythmlink®RLSP5532025-05-16
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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