Rhythmlink®

GUDID 10816312024248

Twisted Corkscrew Subdermal Needles

RHYTHMLINK INTERNATIONAL, LLC

Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode
Primary Device ID10816312024248
NIH Device Record Key05f25dba-efc9-477c-a7ba-9ce678e74135
Commercial Distribution StatusIn Commercial Distribution
Brand NameRhythmlink®
Version Model NumberTSN2320
Company DUNS126290993
Company NameRHYTHMLINK INTERNATIONAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx
Phone8666333754
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS100816312024241 [Primary]
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution
GS110816312024248 [Package]
Contains: 00816312024241
Package: Product Box [12 Units]
In Commercial Distribution

FDA Product Code

GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle
GXZElectrode, Needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [Rhythmlink®]

108163120236853 electrode array, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable [
108163120236473 electrode array, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable [
108163120236302 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120236234 electrode arrays, 10mm Disposable Quick Connect Deep cup Electrode Array with extension cable
108163120236163 electrode array, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable [
108163120236092 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
1081631202355512 electrodes, 13mm long, 0.4mm diameter disposable twisted subdermal needle with touch proof co
1081631202354812 electrodes, 0.6mm diameter twisted corkscrew subdermal needle with touch proof connector
1081631202353112 electrodes, 0.6mm diameter twisted corkscrew subdermal needle with touch proof connector
00816312023527MR Conditional/CT Deep Cups and Disposable Sticky Pads™ Surface Electrodes
00816312023480Monopolar Stimulating Probe
108163120234704 electrode arrays, 10mm Disposable Quick Connect Webb Electrode Array with extension cable [26
108163120234634 electrode arrays, 10mm Disposable Quick Connect Webb Electrode Array with extension cable [26
108163120234564 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120234494 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120234324 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
108163120234254 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
108163120234183 electrode arrays, 10mm Disposable Quick Connect Webb Electrode Array with extension cable [26
108163120234013 electrode arrays, 10mm Disposable Quick Connect Webb Electrode Array with extension cable [26
108163120233953 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120233883 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
108163120233713 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
108163120233643 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
108163120233573 electrode arrays, 10mm Disposable Quick Connect Webb Electrode Array with extension cable [24
108163120233403 electrode arrays, 10mm Disposable Quick Connect Webb Electrode Array with extension cable [24
108163120233333 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120233263 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120233193 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
108163120233023 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
008163120232997 electrodes, 10mm disposable non metallic silver/silver-chloride coated flat disc electrode and
008163120232827 electrodes, MR Conditional disposable EEG Webb electrodes and 15 electrodes, 10mm MR Condition
00816312023213Disposable Slim EEG Cup Electrodes and Recording Sticky Pad Surface Electrodes
108163120232033 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
108163120231972 electrode arrays, 10mm Disposable Quick Connect Slim Cup Electrode Array with extension cable
108163120231803 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120231734 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
10816312023050Twisted Corkscrew Subdermal Needles
108163120230363 electrode arrays, Disposable Webb and Deep Cup with extension cable [22 Pack]
008163120230221 electrode array, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable [
00816312022995Small alligator clip with touch proof connector
00816312022971Monopolar Stimulating Probe
008163120229644 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
008163120229572 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120229303 electrode arrays, Disposable Webb, Slim Cup, and Deep Cup with extension cable [21 Pack]
00816312022926Kit of 3 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension
108163120229163 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
108163120228933 electrode arrays, 10mm Disposable Quick Connect Deep Cup Electrode Array with extension cable
1081631202278710 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof con
108163120227706 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof conn
0081631202266724 electrodes, 10mm disposable non metallic electrode silver/silver-chloride coated and 4 electr

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