IPPS™ Couchtop MTIL301004

GUDID 00841439104583

Siemens ZXT Couchtop with solid panel, Prodigy™ Lok-Bar™, Type-S™ extension, and Type-S™ reloadable frame

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439104583
• NIH Device Record Key: 8f688838-c00c-4708-8703-cf93488cf7ce
• Commercial Distribution Discontinuation: 2020-01-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IPPS™ Couchtop
• Version Model Number: MTIL301004
• Catalog Number: MTIL301004
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841439104583 [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: 6
• Public Version Date: 2020-01-13
• Device Publish Date: 2017-08-02

On-Brand Devices [IPPS™ Couchtop]

• 00841439110966: Reusable non-sterile couchtop for use with Accuray Robocouch
• 00841439106488: One piece couchtop with Lok-Bar™
• 00841439105696: One piece couchtop for use with Elekta X-Box base with Lok-Bar™
• 00841439105689: Couchtop for use with Elekta X-Box base with Lok-Bar™ and endcap
• 00841439105603: Varian Exact™ one piece couchtop with Lok-Bar™
• 00841439105597: Varian Exact™ one piece couchtop with Lok-Bar™
• 00841439105580: Reusable non-sterile Varian Exact™ Couchtop with Lok-Bar™ and endcap
• 00841439105573: Varian Exact™ Couchtop with Lok-Bar™ and endcap
• 00841439105535: Reusable non-sterile couchtop for use with Siemens TXT or Proutra™ with Lok-Bar™ and rectang
• 00841439105290: Siemens ZXT one piece couchtop with Lok-Bar™
• 00841439105283: One piece couchtop with Lok-Bar™ for use with Siemens TXT or Proutra™
• 00841439105191: Reusable non-sterile Siemens ZXT couchtop with Lok-Bar™ and endcap
• 00841439105177: with Lok-Bar™ and endcap for use with Siemens TXT or Proutra™
• 00841439105078: Non-sterile reusable couchtop with Prodigy™ Lok-Bar™ for use with TomoTherapy® Hi-Art Syste
• 00841439104965: Non-sterile reusable couchtop with Prodigy™ Lok-Bar™, couchtop cushions (5), simulator cushi
• 00841439104958: Non-sterile reusable couchtop with Prodigy™ Lok-Bar™, couchtop cushions (5), simulator cushi
• 00841439104934: for use with Accuray® Robocouch
• 00841439104910: Accuray® Cyberknife® couchtop with Prodigy™ Lok-Bar™
• 00841439104620: Siemens TXT couchtop with grid panel, Prodigy™ Lok-Bar™, Type-S™ extension, and Type-S™
• 00841439104583: Siemens ZXT Couchtop with solid panel, Prodigy™ Lok-Bar™, Type-S™ extension, and Type-S™
• 00841439104545: Siemens ZXT couchtop with grid panel, Prodigy™ Lok-Bar™, Type-S™ extension, and Type-S™
• 00841439104538: Siemens Simview Couchtop with Interloc® Lok-Bar™