Universal Couchtop™ MTIL6341

GUDID 00841439105924

GE Discovery STCT couchtop with storage rack

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439105924
• NIH Device Record Key: e789a531-f00a-4f19-83e1-8b41f77e004c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Couchtop™
• Version Model Number: MTIL6341
• Catalog Number: MTIL6341
• 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	00841439105924 [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: 5
• Public Version Date: 2020-03-27
• Device Publish Date: 2017-08-02

On-Brand Devices [Universal Couchtop™]

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• 00841439105375: Siemens ZXT couchtop with Lok-Bar™
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• 00841439105351: For use with Siemens TXT or Proutra™ with Lok-Bar™
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• 00841439112991: Reusable couchtop for IBA L-Series with Lok-Bar™
• 00841439112984: Reusable couchtop for IBA F-Series with Lok-Bar™
• 00841439113622: Siemens Vario 2 CT one piece couchtop with storage rack
• 00841439113608: Siemens Vario 2 CT one piece couchtop
• 00841439113356: Couchtop for Mevion with Lok-Bar™
• 00841439113073: Couchtop for Mevion with Lok-Bar™ and rectangular extension
• 00841439114308: Siemens Biograph mCT UCT LE couchtop with Lok-Bar™
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