IPPS Overlay 20IL430030

GUDID 00841439102084

Reusable non-sterile head panel for use with Calypso 4D Localization System and Varian Exact base

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439102084
• NIH Device Record Key: ef35780b-7497-45d0-99e2-93137363a7d5
• Commercial Distribution Discontinuation: 2019-03-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IPPS Overlay
• Version Model Number: 20IL430030
• Catalog Number: 20IL430030
• 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
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Dimensions

• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter
• Length: 56 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439102084 [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: 2019-03-13
• Device Publish Date: 2017-08-02

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