FDA.reportPublic FDA data

Rhythmlink®

Primary DI
00816312022520
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
RLSP370
Device description
Pep Electrode Kit™
Published
2016-09-17
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
FMFSyringe, Piston
GXZElectrode, Needle
IKTElectrode, Needle, Diagnostic Electromyograph
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
GXZElectrode, NeedleNeurology2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816312022520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816312022520008163120225208163120225200816312022520

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
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
10840330704868ProCureTwin Med, LLCFMF2026-05-27
10840330704875ProCureTwin Med, LLCFMF2026-05-27
08717903490617Humeca MAX Carrier 1:1 Humeca B.V.MDM2026-03-31
08717903490624Humeca MAX Carrier 1:1.5Humeca B.V.MDM2026-03-31
08717903490631Humeca MAX Carrier 1:2Humeca B.V.MDM2026-03-31
08717903490648Humeca MAX Carrier 1:3Humeca B.V.MDM2026-03-31
08717903490716Humeca MAX Carrier 1:2.5Humeca B.V.MDM2026-03-31
08717903490723Humeca MAX Carrier 1:4Humeca B.V.MDM2026-03-31
G318108831520ReconRevelation Medical DevicesMDM2026-03-30
08699207302028Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207305036Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207310030Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207311006Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207320022Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207350029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586026571417SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586026571455SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586026571479SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586026571493SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586026571516SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-03
08586015049637SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-02
08586015049699SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-02
08586026571189SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-02
08586026571202SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-02
08586026571226SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-02
08586026571240SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-02
08586026571264SelfinjectCHIRANA T.Injecta, a. s.FMF2025-10-02