Head Extension MTM340405

GUDID 00841439106761

For use with Philips Ingenia MR overlay

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439106761
• NIH Device Record Key: 6e83a58f-6e9d-4a22-8ff8-a5e863975022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Head Extension
• Version Model Number: MTM340405
• Catalog Number: MTM340405
• 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

Device Dimensions

• Length: 14.2 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439106761 [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: 6
• Public Version Date: 2020-03-12
• Device Publish Date: 2017-08-02

On-Brand Devices [Head Extension]

• 00841439106761: For use with Philips Ingenia MR overlay
• 00841439104590: Head extension with Prodigy™ indexing for use with Siemens ZXT couchtops
• 00841439106792: Reusable non-sterile head extension for use with Philips Ingenia MR overlay