Body Pro-Lok™ System MTSBRT420

GUDID 00841439107621

(53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(1), Type 2 Bridge(1), and Respiratory Plate(1)

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439107621
• NIH Device Record Key: c593f009-55c8-4555-9e4e-32b73a272ae6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Pro-Lok™ System
• Version Model Number: MTSBRT420
• Catalog Number: MTSBRT420
• 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	00841439107621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093738

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2020-03-31
• Device Publish Date: 2017-08-02

On-Brand Devices [Body Pro-Lok™ System]

• 00841439107621: (53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(1), Type 2 Bridge(1), and Re
• 00841439107607: (53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type 2 Bridge(2), Type 3
• 00841439107225: Non-sterile reusable (53cm x 210.8cm) overlay with T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type