138004

GUDID 40653405003183

NEEDLE ELECTRODE 5/8" (2" OVERALL)

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, reusable
Primary Device ID40653405003183
NIH Device Record Keyd43ce3b7-bc20-4037-9af6-d607b79637a1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number138004
Catalog Number138004
Company DUNS071595540
Company NameConmed Corporation
Device Count5
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 Datetrue
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
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
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 Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100653405003185 [Unit of Use]
GS120653405003189 [Package]
Contains: 30653405003186
Package: POUCH [5 Units]
In Commercial Distribution
GS130653405003186 [Primary]
GS140653405003183 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


[40653405003183]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by Conmed Corporation

10653405008125 - NA2024-12-04 CONMED REUSABLE DISPERSIVE ELECTRODE
10653405008132 - NA2024-12-04 CONMED REUSABLE PEDIATRIC DISPERSIVE ELECTRODE
30653405987585 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
30653405987592 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
30653405987608 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
30653405990141 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
20653405990120 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 23 x 25 mm
20653405990137 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 35 x 25 mm

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