MR SBRT Bridge, Large RT-4800-B2

GUDID 10841962110980

MR SBRT Bridge, Large

Qfix

Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system

• Primary Device ID: 10841962110980
• NIH Device Record Key: 3d579210-941a-4a52-89a8-3445fa6ac57f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR SBRT Bridge, Large
• Version Model Number: RT-4800-B2
• Catalog Number: RT-4800-B2
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• 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: false
• Serial Number: true
• 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: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com
• Phone: 610-268-0585
• Email: Compliance@qfix.com

Device Dimensions

• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter
• Width: 60.7 Centimeter
• Height: 48 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962110980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193243

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-12
• Device Publish Date: 2020-03-04

Devices Manufactured by Qfix

• 10841962107386 - Aquaplast PS™: 2023-12-11 Blush, 1/16" - 3" x 3" Nasal Splint Blanks
• 10841962107409 - Aquaplast PS™: 2023-12-11 Blush, 1/16" Small Silver splint, pkg. of 10
• 10841962107423 - Aquaplast PS™: 2023-12-11 Blush, 1/16" Large Silver splint, pkg. of 10
• 10841962107447 - Aquaplast PS™: 2023-12-11 Blush, 1/16" Tie Down Dressings, 6" x 9" sheet
• 10841962107461 - Aquaplast PS™: 2023-12-11 Blush, 1/16", Trapezoidal Nasal Splint, pkg. of 10
• 10841962107485 - Aquaplast PS™: 2023-12-11 Blush, 1/16", Trapezoidal Nasal Splints
• 10841962107492 - Aquaplast PS™: 2023-12-11 Blush, 3/32", 3 x 3" Nasal Splint Blanks
• 10841962107515 - Aquaplast PS™: 2023-12-11 Blush, 3/32", 18" x 24" sheet