Rails-only System

Basic Information

• Brand Name: Rails-only System
• Primary DI: 00841439107522
• Version / Model: MTSBRT059
• Catalog Number: MTSBRT059
• Company Name: MEDTEC, INC.
• Labeler DUNS: 103977526
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-02
• Public Version: 8
• Public Version Date: 2022-08-01
• Public Version Status: Update
• Public Device Record Key: 075aa879-3290-41ca-8734-43ec81362c54
• Distribution End Date: 2022-07-30

Device Description

53cm MI

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
IXQ	Table, radiographic, stationary top	Radiology	892.1980	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	00841439107522	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973842	000

Device Sizes

Type	Value	Unit	Text
Width	23.3	Inch
Length	43	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Storage Environment Temperature
• Temperature Range: 52 – 85 Degrees Fahrenheit