Overlay MTM6508

GUDID 00841439112762

with Lok-Bar™ for use with Canon Orian

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439112762
• NIH Device Record Key: 26073dca-22a4-4a42-bc33-224bdf8b6e3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Overlay
• Version Model Number: MTM6508
• Catalog Number: MTM6508
• 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: true
• 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

Device Dimensions

• Length: 2011 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439112762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080072

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: 3
• Public Version Date: 2020-03-19
• Device Publish Date: 2019-03-13

On-Brand Devices [Overlay]

• 00841439112762: with Lok-Bar™ for use with Canon Orian
• 00841439112694: with body coil support, head coil support, and Lok-Bar™ for use with Canon Orian
• 00841439111796: with Lok-Bar™ for use with Canon Vantage Galan 3T
• 00841439111765: with body coil support, head coil support, and Lok-Bar™ for use with Canon Vantage Galan 3T
• 00841439113288: With Lok-Bar™ for use with Siemens MR Sola and Vida
• 00841439113271: With body coil support, head coil support, and Lok-Bar™ for use with Siemens MR Sola and Vida