IPPS™ Couchtop MTIL3603

GUDID 00841439104958

Non-sterile reusable couchtop with Prodigy™ Lok-Bar™, couchtop cushions (5), simulator cushions (7) and baseplate for use with Accuray® RoboCouch®

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439104958
• NIH Device Record Key: c2bdfcd9-0ebb-4222-abc4-8b54d3145085
• Commercial Distribution Discontinuation: 2020-01-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IPPS™ Couchtop
• Version Model Number: MTIL3603
• Catalog Number: MTIL3603
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439104958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933227

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: 7
• Public Version Date: 2020-01-02
• Device Publish Date: 2017-08-02

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