Protura 206X140

GUDID 00841439101971

Protura, Kit, Elekta Precise

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439101971
• NIH Device Record Key: 71c3dcc7-b43d-457a-8dff-c349ac5f801a
• Commercial Distribution Discontinuation: 2019-06-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Protura
• Version Model Number: 206X140
• Catalog Number: 206X140
• 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: 5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439101971 [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: 2019-06-17
• Device Publish Date: 2017-08-02

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• 00841439101971: Protura, Kit, Elekta Precise
• 00841439101964: Protura, Kit, Varian Exact
• 00841439101957: Protura, Kit, Siemens Txt
• 00841439110140: Protura Robotic Couch System Version 1.6.1
• 00841439102930: Protura Software Manual
• 00841439102893: Protura Robotic Couch System Version 1.5.0
• 00841439102855: Protura Robotic Couch System Version 1.4.0