FDA.reportPublic FDA data

Rhythmlink®

Primary DI
10816312021599
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
MRP525
Device description
12 electrodes, 7mm diameter MR Conditional PressOn Electrode with touch proof connector and MR Unsafe Extension Cable
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
10816312021599PackageGS112In Commercial Distribution
00816312021592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631202159910816312021599
00816312021592008163120215928163120215920816312021592

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8666333754xx@xx.xx

Regulatory Flags#

DUNS number
126290993
Device count
1
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816312024401RHYTHMLINK INTERNATIONAL, LLCRLSP5332022-01-12
00816312028065Rhythmlink®MRQWS423152026-05-18
10816312028048Rhythmlink®MRDC25152026-03-30
10816312027966Rhythmlink®DC31152026-02-13
00816312027969Rhythmlink®DC31152026-02-13
10816312027959Rhythmlink®DC2415202026-01-12
00816312027945Rhythmlink®MRQWD3040405152026-01-12
00816312025910Rhythmlink®SP2100012021-08-06
00816312027921Rhythmlink®MRQD31006101522025-12-08
00816312027853Rhythmlink®CTGN2121-2.52025-12-05
10816312027850Rhythmlink®CTGN2121-2.52025-12-05
00816312027860Rhythmlink®CTGN2121-2.52025-12-03
10816312027867Rhythmlink®CTGN2121-2.52025-12-03
00816312027907Rhythmlink®DCDECUL3315202025-11-21
00816312027914Rhythmlink®SCDECUS2610152025-11-21
10816312027898Rhythmlink®DC29152025-11-07
10816312023104Rhythmlink®RLSP5222020-06-02
00816312025163Rhythmlink®RLSP531C2022-09-21
00816312027020Rhythmlink®MRQD3291532023-10-24
00816312026979Rhythmlink®MRQD3231522023-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08718375869062AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869123AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375868102Consolidated Neuro SupplyTechnomed Engineering B.V.GXZ2021-06-02
08718375867129NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867143NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867167NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867181NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867204NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867228NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867242NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867266NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867280NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867303NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867556Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
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08718375867327Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867341Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867365Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375866672Neurosign V4Technomed Engineering B.V.GXZ2020-07-22
08718375867785Technomed EuropeTechnomed Engineering B.V.GXZ2020-07-22