CONCEPT ESA-5130

GUDID 10845854035573

CONCEPT ABLATOR ELECTRODE, 30 DEGREE (ELECTRODE ONLY), QTY 5

Conmed Corporation

Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 10845854035573
• NIH Device Record Key: 57e9dd5d-b896-45e9-bfac-d89bfaa2fae6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONCEPT
• Version Model Number: ESA-5130
• Catalog Number: ESA-5130
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree
• Angle: 30 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845854035576 [Unit of Use]
GS1	10845854035573 [Package]; Contains: 20845854035570; Package: BOX [5 Units]; In Commercial Distribution
GS1	20845854035570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983652

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [CONCEPT]

• 20845854035600: CONCEPT ABLATOR, 90 DEGREE MINI KIT
• 10845854035597: CONCEPT ABLATOR ELECTRODE, 90 DEGREE (ELECTRODE ONLY), QTY 5
• 20845854035587: CONCEPT ABLATOR, 30 DEGREE BASIC KIT
• 10845854035573: CONCEPT ABLATOR ELECTRODE, 30 DEGREE (ELECTRODE ONLY), QTY 5
• 20845854027056: CONCEPT ABLATOR, 90 DEGREE BASIC KIT
• 20845854027049: CONCEPT ABLATOR, 30 DEGREE MINI KIT
• 20845854031299: CONCEPT ROTARY PUNCH, 90 DEGREE, RIGHT
• 20845854031282: CONCEPT ROTARY PUNCH, 90 DEGREE, LEFT
• 20845854031275: CONCEPT LINEAR GRASPER, LARGE BODY
• 20845854031206: CONCEPT SUTURE TRAM RETROGRADE SUTURE RETRIEVER, CURVED 15 DEGREE
• 20845854031190: CONCEPT SUTURE TRAM RETROGRADE SUTURE RETRIEVER, STRAIGHT
• 20845854031350: CONCEPT LINEAR SCISSOR PUNCH, UP 15 DEG
• 20845854031336: CONCEPT 1.3MM PUNCH, STRAIGHT
• 20845854031329: CONCEPT WIDE BITE PUNCH, UP 15 DEG UPSWEPT
• 20845854031305: CONCEPT LINEAR WIDE BITE PUNCH, STRAIGHT
• 20845854031268: CONCEPT ROTARY SCISSOR, 20 DEGREE, RIGHT
• 20845854031251: CONCEPT ROTARY SCISSOR, 20 DEGREE, LEFT
• 20845854031244: CONCEPT LINEAR SCISSOR PUNCH, STRAIGHT
• 20845854031237: CONCEPT LINEAR NARROW PUNCH, STRAIGHT
• 20845854031220: CONCEPT LINEAR WIDE BITE PUNCH, UP 15 DEG, CURVED RIGHT
• 20845854031213: CONCEPT LINEAR WIDE BITE PUNCH, UP 15 DEG, CURVED LEFT
• 10845854031414: CONCEPT LINEAR PUNCH, OBLIQUE, CURVED RIGHT
• 20845854031404: CONCEPT LINEAR PUNCH, OBLIQUE, CURVED LEFT
• 10845854031391: CONCEPT LINEAR WIDE BITE PUNCH, UP 15 DEGREE, BLUNT NOSE
• 10845854031360: CONCEPT LINEAR GRASPER, ALLIGATOR
• 20845854031343: CONCEPT 1.3MM PUNCH, 15 DEGREE UP
• 20845854031312: CONCEPT LINEAR WIDE BITE PUNCH, UP 15 DEGREE
• 20845854031183: CONCEPT GRASPER, CUPPED
• 20845854031176: Concept Punch, Retro, Right
• 20845854031169: Concept Punch, Retro, Left
• 20845854031152: Concept Punch, Meniscal Lift, Straight
• 10845854027059: CONCEPT ABLATOR, 90 DEGREE BASIC KIT
• 10845854027042: CONCEPT ABLATOR, 30 DEGREE MINI KIT
• 20845854029531: CONCEPT ABLATOR ELECTRODE, 90 DEGREE (ELECTRODE ONLY)