Fixator™ MTCFHN006

GUDID 00841439104125

Shoulder suppression system with attached strap and thermoplastic frame

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439104125
• NIH Device Record Key: 44e00d13-219e-4bc3-865d-fcf21845fd4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixator™
• Version Model Number: MTCFHN006
• Catalog Number: MTCFHN006
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439104125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933227

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: 2020-03-19
• Device Publish Date: 2017-08-02

Devices Manufactured by MEDTEC, INC.

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• 10841439113667 - ProForm™ Thermoplastic: 2024-02-20 IMRT FreedomView thermoplastic (3.2mm)
• 10841439113674 - ProForm™ Thermoplastic: 2024-02-20 IMRT style 18 thermoplastic (3.2mm)
• 10841439113681 - ProForm™ Thermoplastic: 2024-02-20 IMRT Clear Vision 2 open face thermoplastic (3.2mm)
• 10841439113698 - ProForm™ Thermoplastic: 2024-02-20 IMRT FreedomView thermoplastic (3.2mm)
• 10841439113704 - ProForm™ Thermoplastic: 2024-02-20 IMRT Clear Vision 2 open face thermoplastic (3.2mm)
• 00841439114490 - Molded Hand Grip: 2024-02-20 For use with Pro Wing Board™ or Monarch™
• 00841439114513 - Mevion Rectangular Backrest: 2024-02-12 For use with Mevion S250-FIT Proton Therapy System™