Rails-only System MTSBRT051

GUDID 00841439107454

53cm Prodigy™

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439107454
• NIH Device Record Key: cebada58-6a22-440e-92c0-a9d84e135d29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rails-only System
• Version Model Number: MTSBRT051
• Catalog Number: MTSBRT051
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Dimensions

• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch
• Length: 43 Inch
• Width: 23.6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439107454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111340

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-30
• Device Publish Date: 2017-08-02

On-Brand Devices [Rails-only System]

• 00841439107522: 53cm MI
• 00841439107478: 50cm Prodigy™
• 00841439107461: 50cm Interloc®
• 00841439107454: 53cm Prodigy™
• 00841439107447: 53cm Interloc®
• 00841439110324: 53cm Varian Exact™