Body Pro-Lok™ System MTSBRT001

GUDID 00841439107225

Non-sterile reusable (53cm x 210.8cm) overlay with T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type 2 Bridge(2), Type 3 Bridge(1), Shoulder Bridge 2(1), Forehead Restraint(1), and 8" Clam-Lok™ Cushion(1)

MEDTEC, INC.

Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner

• Primary Device ID: 00841439107225
• NIH Device Record Key: 90fc19d9-8578-4c2d-b400-03498851eaac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Pro-Lok™ System
• Version Model Number: MTSBRT001
• Catalog Number: MTSBRT001
• 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: 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
• 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
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439107225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935300

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: 6
• Public Version Date: 2019-05-31
• 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