Proutra™ MT6XSM1.7.4

GUDID 00841439111703

Proutra™ Robotic Couch System Version 1.7.4

MEDTEC, INC.

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• Primary Device ID: 00841439111703
• NIH Device Record Key: 09d42208-15f0-493d-a0c8-7fbc31598b64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proutra™
• Version Model Number: MT6XSM1.7.4
• Catalog Number: MT6XSM1.7.4
• 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
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439111703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132084

FDA Product Code

• JAI: Couch, radiation therapy, powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-12-01

On-Brand Devices [Proutra™]

• 00841439111703: Proutra™ Robotic Couch System Version 1.7.4
• 00841439111376: Proutra™ Robotic Couch System Version 1.7.3
• 00841439102794: Replacement calibration fixture
• 00841439102787: Reconditioned, for use with Elekta Precise bases
• 00841439102770: For use with Elekta Precise bases
• 00841439102763: Reconditioned, for use with Varian Exact™ bases
• 00841439102756: For use with Varian Exact™ bases
• 00841439102749: Reconditioned, for use with Siemens TXT bases
• 00841439102732: For use with Siemens TXT bases