Protura 1.7.2 MT6XSM1.7.2

GUDID 00841439110652

Protura™ Robotic Couch System Version 1.7.2

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439110652
• NIH Device Record Key: 3003094a-fe5d-48db-9c40-199db3d37ea4
• Commercial Distribution Discontinuation: 2018-05-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Protura 1.7.2
• Version Model Number: MT6XSM1.7.2
• Catalog Number: MT6XSM1.7.2
• 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: 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

• Length: 11 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439110652 [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: 2018-07-06
• Device Publish Date: 2017-08-02

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