TracPatch 4000-0-1000

GUDID 00844588044311

Knee System

CONSENSUS ORTHOPEDICS, INC.

Electronic goniometer/kinesiology sensor

• Primary Device ID: 00844588044311
• NIH Device Record Key: 5aec659d-1127-4b00-817e-43c80f69603d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TracPatch
• Version Model Number: 4000-0-1000
• Catalog Number: 4000-0-1000
• Company DUNS: 824905723
• Company Name: CONSENSUS ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com
• Phone: +1(916)355-7100
• Email: ntovar@consensusortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844588044311 [Primary]

FDA Product Code

• KQX: Goniometer, ac-powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-03
• Device Publish Date: 2020-03-26

Devices Manufactured by CONSENSUS ORTHOPEDICS, INC.

• 00844588044311 - TracPatch: 2020-04-03Knee System
• 00844588044311 - TracPatch: 2020-04-03 Knee System
• 00844588006111 - Consensus® Knee System: 2019-12-11 Femoral Component, Cemented
• 00844588006128 - Consensus® Knee System: 2019-12-11 Femoral Component, Cemented
• 00844588006135 - Consensus® Knee System: 2019-12-11 Femoral Component, Cemented
• 00844588006142 - Consensus® Knee System: 2019-12-11 Femoral Component, Cemented
• 00844588006159 - Consensus® Knee System: 2019-12-11 Femoral Component, Cemented
• 00844588006166 - Consensus® Knee System: 2019-12-11 Femoral Component, Cemented
• 00844588006173 - Consensus® Knee System: 2019-12-11 Femoral Component, Cemented