FDA.reportPublic FDA data

Rhythmlink®

Primary DI
00816312024937
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
221-28SS-730
Device description
20 Paired Fine Wire Needle Electrodes, EMG, 30mm x 27g
Published
2021-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816312024934PackageGS120In Commercial Distribution
00816312024937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631202493410816312024934
00816312024937008163120249378163120249370816312024937

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge27Gauge

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
00816312027969Rhythmlink®DC31152026-02-13
00816312027921Rhythmlink®MRQD31006101522025-12-08
10816312027850Rhythmlink®CTGN2121-2.52025-12-05
10816312027867Rhythmlink®CTGN2121-2.52025-12-03
00816312027792Rhythmlink®MRSWB14152025-09-29
10816312027805Rhythmlink®MRQSWB20908152025-09-24
10816312027812Rhythmlink®MRQD3080807152025-09-05
00816312027365Rhythmlink®GNFD5152025-07-30
00816312027372Rhythmlink®GNFD51522025-07-30
00816312027785Rhythmlink®CTDC2615202025-07-24
00816312027761Rhythmlink®DC21152025-07-23
00816312027778Rhythmlink®DC271522025-07-23
00816312027709Rhythmlink®RLSP5522025-05-16
00816312027716Rhythmlink®RLSP5532025-05-16
00816312027723Rhythmlink®RLSP5542025-05-16
00816312027730Rhythmlink®RLSP5552025-05-16
00816312027747Rhythmlink®RLSP5562025-05-16
10816312027652Rhythmlink®RLSND801-2.52025-05-05
10816312027669Rhythmlink®RLSND802-2.52025-05-05
10816312027690Rhythmlink®MRQDW106302025-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791378530CadwellTechnomed Engineering B.V.IKT2025-12-10
08720791378011CadwellTechnomed Engineering B.V.IKT2025-07-16
08720791378035CadwellTechnomed Engineering B.V.IKT2025-07-15
08720791375911CadwellTechnomed Engineering B.V.IKT2025-03-12
08054655008418Disposable EMG needle electrodesSPES MEDICA SPAIKT2025-03-03
08054655023350Disposable EMG needle electrodesSPES MEDICA SPAIKT2025-03-03
08720791376642CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791376680CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791376727CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791377861CadwellTechnomed Engineering B.V.IKT2025-01-16
08720791375232Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375256Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375355Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375379Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375393Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375416Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375478Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375515Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791377229Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377243Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377267Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377281Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377304Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377328Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377335CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377342CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377359CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377366CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377373CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377380CadwellTechnomed Engineering B.V.IKT2024-11-15