IPPS Couchtop MTIL6160

GUDID 00841439105665

Reusable non-sterile Varian Exact Couchtop with Lok-Bar and endcap rectangular extension

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439105665
• NIH Device Record Key: 6d0a30cf-5ed3-44e8-85e8-de2055999b9e
• Commercial Distribution Discontinuation: 2019-03-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IPPS Couchtop
• Version Model Number: MTIL6160
• Catalog Number: MTIL6160
• 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: 22.6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439105665 [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: 4
• Public Version Date: 2019-03-20
• Device Publish Date: 2017-08-02

On-Brand Devices [IPPS Couchtop]

• 00841439105726: Reusable non-sterile couchtop for use with Elekta X-Box base with Lok-Bar and rectangular extens
• 00841439105665: Reusable non-sterile Varian Exact Couchtop with Lok-Bar and endcap rectangular extension
• 00841439105542: Reusable non-sterile Siemens ZXT couchtop with Lok-Bar and rectangular extension