FSR3XX

GUDID 10653405004608

RE-ORDER TAG

Conmed Corporation

Electrocardiographic lead set, reusable
Primary Device ID10653405004608
NIH Device Record Key601bc3a2-ef62-4914-be85-b711b5f5756f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberFSR3XX
Catalog NumberFSR3XX
Company DUNS071595540
Company NameConmed Corporation
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS110653405004608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-06-06
Device Publish Date2016-09-24

Devices Manufactured by Conmed Corporation

00810021867373 - CoLink®2025-07-11 CoLink® Afx, Locking Screw, 2.7X14.0MM, 2-Pack
00810021867380 - CoLink®2025-07-11 CoLink® Afx, Locking Screw, 2.7X16.0MM, 2-Pack
00810021867403 - CoLink®2025-07-11 CoLink® Afx, Locking Screw, 3.5X12.0MM, 2-Pack
00810021867410 - CoLink®2025-07-11 CoLink® Afx, Locking Screw, 3.5X14.0MM, 2-Pack
00810021867427 - CoLink®2025-07-11 CoLink® Afx, LOW-PRO CORTICAL SCREW, 3.5X12.0MM, 2-Pack
00810021867434 - CoLink®2025-07-11 CoLink® Afx, LOW-PRO CORTICAL SCREW, 3.5X14.0MM, 2-Pack
08101755018714 - CoLink®2025-07-11 CoLink® Afx, Locking Screw, 3.5X10.0MM, 2-Pack
08101755018721 - CoLink®2025-07-11 CoLink® Afx, Locking Screw, 3.5X16.0MM, 2-Pack

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