FDA.reportPublic FDA data

Rhythmlink®

Primary DI
10816312020554
Brand
Rhythmlink®
Company
RHYTHMLINK INTERNATIONAL, LLC
Model
RLSND824-1.5
Device description
10 electrodes, 13mm long, 0.4mm diameter disposable paired subdermal needle with touch proof connector
Published
2016-09-17
Public version status
Update
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
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816312020554PackageGS110In Commercial Distribution
00816312020557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631202055410816312020554
00816312020557008163120205578163120205570816312020557

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length13Millimeter

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
08720791377700InomedTechnomed Engineering B.V.GXZ2025-12-10
10816312027850Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-12-05
10816312027867Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-12-03
00816312027365Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-07-30
00816312027372Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-07-30
08720791377656CadwellTechnomed Engineering B.V.GXZ2025-05-26
08720791377670CadwellTechnomed Engineering B.V.GXZ2025-05-26
00816312027709Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027716Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027723Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027730Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
00816312027747Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
10816312027652Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10816312027669Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10841019116910KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-07
10841019122409KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
10841019122416KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
10841019122423KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
08720791374587NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374600NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374624NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374648NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374662NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374686NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791375706CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375720CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375744CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375768CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375782CadwellTechnomed Engineering B.V.GXZ2025-02-28
10816312027515Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-02-26