Prodigy Lok-Bar 20IL430020

GUDID 00841439102077

(53cm) Calypso

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439102077
• NIH Device Record Key: 02a9e3d1-e637-4e59-ac2b-f0a52eee8fab
• Commercial Distribution Discontinuation: 2019-03-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Prodigy Lok-Bar
• Version Model Number: 20IL430020
• Catalog Number: 20IL430020
• 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

Device Dimensions

• Width: 1 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439102077 [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 [Prodigy Lok-Bar]

• 00841439105016: Reusable non-sterile (53cm) calibration bar for use with Accuray Cyberknife
• 00841439102077: (53cm) Calypso
• 00841439102060: (53cm) Calypso