SilverRest Resting ECG TAB Electrode 6500045V

GUDID 00009336010332

SilverRest Resting ECG TAB Electrode

GRAPHIC CONTROLS ACQUISITION CORP

Electrocardiographic electrode, single-use
Primary Device ID00009336010332
NIH Device Record Key71ffeba2-60fb-428a-95b1-76523a1f6c72
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilverRest Resting ECG TAB Electrode
Version Model NumberA10024
Catalog Number6500045V
Company DUNS002111896
Company NameGRAPHIC CONTROLS ACQUISITION CORP
Device Count100
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com
Phone8006696905
EmailHSInfo@nisshamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100009336010332 [Unit of Use]
GS110009336010339 [Primary]
GS130009336010333 [Package]
Contains: 10009336010339
Package: Box [1000 Units]
In Commercial Distribution
GS150009336010337 [Package]
Contains: 30009336010333
Package: Case [10000 Units]
In Commercial Distribution

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-22
Device Publish Date2024-11-14

Devices Manufactured by GRAPHIC CONTROLS ACQUISITION CORP

00009336010332 - SilverRest Resting ECG TAB Electrode2024-11-22SilverRest Resting ECG TAB Electrode
00009336010332 - SilverRest Resting ECG TAB Electrode2024-11-22 SilverRest Resting ECG TAB Electrode
00009336002559 - Vermed2024-06-06 3-Lead,Safety Din to Mini Pinch,29" Leadwire Set
00009336002573 - Vermed2024-06-06 3 Lead DIN to Pinch, 29", AHA
00009336002597 - Vermed2024-06-06 LWG-3090029/5A 5 Lead DIN to Pinch, 29IN AHA
00009336002603 - Vermed2024-06-06 Leadwire Safety Din To Snap, 29" Green-RL
00009336002610 - Vermed2024-06-06 Leadwire Safety Din to Snap, 29" Red-LL
00009336002627 - Vermed2024-06-06 Leadwire Safety Din To Snap, 29" White-RA
00009336002665 - Vermed2024-06-06 3 Lead Safety DIN to Snap, 29", AHA

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