Protura 1.7.1 MT6XSM1.7.1

GUDID 00841439110539

Protura™ Robotic Couch System Version 1.7.1

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439110539
• NIH Device Record Key: cebb11ec-422f-47f0-be3a-17b7ffb225ee
• Commercial Distribution Discontinuation: 2017-08-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Protura 1.7.1
• Version Model Number: MT6XSM1.7.1
• Catalog Number: MT6XSM1.7.1
• 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: false
• 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: 8.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439110539 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-02

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