ONEBridge™ BPL001

GUDID 00841439102275

ONEBridge™

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439102275
• NIH Device Record Key: c285ef80-5a57-4a95-a0d3-41b366069178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONEBridge™
• Version Model Number: BPL001
• Catalog Number: BPL001
• 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
• 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
• 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	00841439102275 [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: 6
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-08-02

Devices Manufactured by MEDTEC, INC.

• 00841439114766 - Universal Couchtop™: 2024-10-28 with Lok-Bar™ and rectangular extension
• 00841439114667 - GE MR Posifix® Baseplate: 2024-10-09 Acrylic Baseplate
• 00841439114759 - Rectangular Extension: 2024-10-09 For use with Universal Couchtop™ Long Extension
• 00841439114612 - Wedge: 2024-07-17 5 degree wedge, MR
• 00841439114629 - Spacer: 2024-07-17 20mm spacer, MR
• 00841439114636 - Spacer: 2024-07-17 30mm spacer, MR
• 00841439114643 - Wedge and Spacer Set: 2024-07-17 2.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer, MR
• 10841439114589 - BrachyGel Vaginal Hydrogel Packing System: 2024-05-31 BrachyGel Vaginal Hydrogel Packing System (BVHPS)