Couchtop Panel MTIL3103

GUDID 00841439104699

For use with Varian Exact™ system

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439104699
• NIH Device Record Key: cf7e4374-b3ec-4830-aebe-14b70775a620
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Couchtop Panel
• Version Model Number: MTIL3103
• Catalog Number: MTIL3103
• 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 Dimensions

• Length: 36.2 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439104699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973842

FDA Product Code

• IXQ: Table, radiographic, stationary top

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 [Couchtop Panel]

• 00841439108932: Reusable non-sterile solid couchtop panel for use with Siemens ZXT or Z4 systems
• 00841439108925: Reusable non-sterile grid couchtop panel for use with Siemens ZXT or Z4 systems
• 00841439104729: Reusable non-sterile tangential couchtop panel for use with Nucletron Simulix-HP
• 00841439104699: For use with Varian Exact™ system
• 00841439104576: Reusable non-sterile solid couchtop panel for use with Siemens ZXT system
• 00841439104569: Reusable non-sterile tangental coutchtop panel for use with Siemens ZXT system
• 00841439104552: Reusable non-sterile grid couchtop panel for use with Siemens ZXT system
• 00841439104491: Reusable non-sterile solid couchtop panel for use with Siemens ZXT system