AC03

GUDID 10653405004561

3-LEAD COMBINER

Conmed Corporation

Electrocardiographic lead set, reusable
Primary Device ID10653405004561
NIH Device Record Key9b7dca6e-3143-4858-a9d3-c716b9101ef1
Commercial Distribution Discontinuation2020-10-13
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberAC03
Catalog NumberAC03
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
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
GS110653405004561 [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 Number4
Public Version Date2020-10-14
Device Publish Date2016-09-24

Devices Manufactured by Conmed Corporation

20653405990120 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 23 x 25 mm
20653405990137 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 35 x 25 mm
20653405990144 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 40 x 60 mm
20653405990151 - BioBrace2024-09-30 BioBrace® Reinforced Implant, Foot & Ankle, 40 x 60 mm
30845854053137 - MEGADYNE2024-08-21 Filter Fluid Trap
30653405990196 - PlumeSafe® X5™2024-08-21 Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports
10653405987550 - PlumeSafe® X5™2024-08-20 Smoke Evacuation Unit with PlumeSafe X5 Smoke Evacuation Filter
10653405987994 - PlumeSafe® X5™2024-08-20 Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.