Shim MTSHIM01S

GUDID 00841439107645

For use with Type-S™ system

MEDTEC, INC.

Radiological headrest

• Primary Device ID: 00841439107645
• NIH Device Record Key: 6141312f-8c60-44f0-8209-2d79e81515cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shim
• Version Model Number: MTSHIM01S
• Catalog Number: MTSHIM01S
• 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: 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

• Width: 47.3 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439107645 [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: 5
• Public Version Date: 2020-03-19
• Device Publish Date: 2017-08-02

On-Brand Devices [Shim]

• 00841439107669: For use with Timo headrests
• 00841439107652: For use with Silverman headrests
• 00841439107645: For use with Type-S™ system
• 00841439107638: For use with Silverman headrests