Body Pro-Lok™ Platform MTSBRT070

GUDID 00841439107539

(53cm x 143cm) overlay with MR T-Pin Lok-Bar™s(2)

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439107539
• NIH Device Record Key: b3289aef-dfc7-4de3-81c1-9e0d47cb7da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Pro-Lok™ Platform
• Version Model Number: MTSBRT070
• Catalog Number: MTSBRT070
• 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	00841439107539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111340

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: 7
• Public Version Date: 2020-03-19
• Device Publish Date: 2017-08-02

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

• 00841439107539: (53cm x 143cm) overlay with MR T-Pin Lok-Bar™s(2)
• 00841439107249: (53cm x 210.8cm) overlay