Prodigy™ Lok-Bar™ MTIL3454

GUDID 00841439104880

(50cm)

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439104880
• NIH Device Record Key: 6bfa2069-a190-4f43-9022-8c2e09d4ffdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy™ Lok-Bar™
• Version Model Number: MTIL3454
• Catalog Number: MTIL3454
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00841439104880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080072

FDA Product Code

• IYE: Accelerator, linear, medical

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: 2019-05-31
• Device Publish Date: 2017-08-02

On-Brand Devices [Prodigy™ Lok-Bar™]

• 00841439105009: (53cm)
• 00841439104996: Transverse (53cm)
• 00841439104989: (50cm)
• 00841439104972: (53cm)
• 00841439104897: (40cm)
• 00841439104880: (50cm)