FDA.reportPublic FDA data

Rhythmlink®

Primary DI
00816312022223
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
RLSP210
Catalog number
03.809.002S
Device description
Oracle Neuromonitoring Kit
Published
2016-09-21
Public version status
Update
Distribution status
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
ETNStimulator, Nerve
GXYElectrode, Cutaneous
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GXYElectrode, CutaneousNeurology2
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816312022223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816312022223008163120222238163120222230816312022223

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
8666333754xx@xx.xx

Regulatory Flags#

DUNS number
126290993
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08718375866061Neurosign V4Technomed Engineering B.V.ETN2022-07-04
00816312024401RHYTHMLINK INTERNATIONAL, LLCRHYTHMLINK INTERNATIONAL, LLCGXY2022-01-12
08600053881032EpilogEpitel, Inc.GXY2022-01-01
08600053881650REMIEpitel, Inc.GXY2022-01-01
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
08718375867037CadwellTechnomed Engineering B.V.GXY2020-11-13
08718375867051CadwellTechnomed Engineering B.V.GXY2020-11-13
08718375867075CadwellTechnomed Engineering B.V.GXY2020-11-13
08718375867099CadwellTechnomed Engineering B.V.GXY2020-11-13
08718375866672Neurosign V4Technomed Engineering B.V.GXZ2020-07-22
08718375861707Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08718375866788Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08718375866801Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08718375866825Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08718375866849Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08718375866863Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08718375866726Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-20
08718375866740Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-20
08718375866764Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-20
08718375866542NatusTechnomed Engineering B.V.GXZ2019-07-24
08718375866580NatusTechnomed Engineering B.V.GXZ2019-07-24