ZiFix Traverse

Basic Information

• Brand Name: ZiFix Traverse
• Primary DI: 00841439114841
• Version / Model: RT-4558CB04
• Catalog Number: RT-4558CB04
• Company Name: MEDTEC, INC.
• Labeler DUNS: 103977526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-12
• Public Version: 1
• Public Version Date: 2025-09-22
• Public Version Status: New
• Public Device Record Key: 2f16fae1-bd4f-461a-8ca2-dd8943f5399b

Device Description

ZiFix Traverse with ONEClamp

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2
JAI	Couch, Radiation Therapy, Powered	Radiology	892.5770	2
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2
KPS	System, Tomography, Computed, Emission	Radiology	892.1200	2
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	892.5050	2
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	892.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40902	Radiological whole-body positioner	A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841439114841	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171133	000