CONCEPT ESA-5130M

GUDID 10845854027042

CONCEPT ABLATOR, 30 DEGREE MINI KIT

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 Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 10845854027042
• NIH Device Record Key: 7e748c51-fdc9-4548-b0fb-ff639535c0ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONCEPT
• Version Model Number: ESA-5130M
• Catalog Number: ESA-5130M
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@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
• Angle: 30 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854027042 [Primary]
GS1	20845854027049 [Previous]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-13
• Device Publish Date: 2023-12-05

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)