Proutra™

Basic Information

• Brand Name: Proutra™
• Primary DI: 00841439102794
• Version / Model: MT6XCALS
• Catalog Number: MT6XCALS
• Company Name: MEDTEC, INC.
• Labeler DUNS: 103977526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-02
• Public Version: 7
• Public Version Date: 2019-06-17
• Public Version Status: Update
• Public Device Record Key: af272b87-fd4d-4f28-9242-24f8c7c6407f

Device Description

Replacement calibration fixture

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: Labeling does not contain MRI Safety Information
• 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
JAI	Couch, radiation therapy, powered	Radiology	892.5770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40687	Accelerator system table, powered	An electrically-powered and/or programmable radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs that includes electronic and/or software controls for top height adjustments and positioning. It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841439102794	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031866	000