Type-S™ Overlay 20CFHNSUB2

GUDID 00841439102022

with attached strap

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439102022
• NIH Device Record Key: 030ef1c7-e903-4498-89dd-47e90904e368
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Type-S™ Overlay
• Version Model Number: 20CFHNSUB2
• Catalog Number: 20CFHNSUB2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439102022 [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: 2020-03-19
• Device Publish Date: 2017-08-02

On-Brand Devices [Type-S™ Overlay]

• 00841439111390: with attached strap (No Vac-Lok™ Index)
• 00841439109939: Type-S™ Overlay
• 00841439107119: Reusable overlay with thermoplastic frame for use with Hitachi proton system
• 00841439106860: with strap
• 00841439106853: with strap
• 00841439102022: with attached strap