TracPatch

Basic Information

• Brand Name: TracPatch
• Primary DI: 00844588044311
• Version / Model: 4000-0-1000
• Catalog Number: 4000-0-1000
• Company Name: CONSENSUS ORTHOPEDICS, INC.
• Labeler DUNS: 824905723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-26
• Public Version: 1
• Public Version Date: 2020-04-03
• Public Version Status: New
• Public Device Record Key: 5aec659d-1127-4b00-817e-43c80f69603d

Device Description

Knee System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQX	Goniometer, ac-powered	Orthopedic	888.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33652	Electronic goniometer/kinesiology sensor	A small electronic device designed to be fastened to a body part (e.g., a patient worn goniometer-, accelerometer-, or gyroscope-sensor), or hand-held by a clinician (e.g., goniometer), to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. Acquired data may be transferred to a computing device/software for recording/display and analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844588044311	GS1

Customer Contacts

• Phone: [phone] ext. 154
• Email: [email protected]