Fibreplast® Assure™ Open View RT-1876KYSDGLF

GUDID 10841962114476

Fibreplast Open View Split S-Frame 3.2mm

Qfix

Patient positioning thermoplastic mould material

• Primary Device ID: 10841962114476
• NIH Device Record Key: d7fde033-5b88-4e2b-9eb9-1dff89f911ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fibreplast® Assure™ Open View
• Version Model Number: RT-1876KYSDGLF
• Catalog Number: RT-1876KYSDGLF
• 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: true
• 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(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com

Device Dimensions

• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter
• Depth: 3.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962114476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935067

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: 2021-12-24
• Device Publish Date: 2021-12-16

On-Brand Devices [Fibreplast® Assure™ Open View]

• 10841962111949: Assure Open View Fibreplast PR 5-Point, 2.4 mm Locks
• 10841962111925: Assure Open View Fibreplast PR 5-Point, 2.4 mm Locks
• 10841962111765: Assure Open View Fibreplast 5 Point Mask
• 10841962111741: Assure Open View Fibreplast 5 Point Mask
• 10841962111734: Assure Open View Fibreplast 3-Point Mask
• 10841962111710: Assure Open View Fibreplast 3-Point Mask
• 10841962111673: Fibreplast Open Views HD Only Split U-Frame Ext
• 10841962111659: Fibreplast Open Views HD Only Split U-Frame Ext
• 10841962111581: Fibreplast Open View Slim Split-Frame U-Frame Ext
• 10841962111567: Fibreplast Open View Slim Split-Frame U-Frame Ext
• 10841962113479: Fibreplast Open View Hd + Shldr 2.4mm Micro Perf
• 10841962113455: Fibreplast Open View Hd + Shldr 2.4mm Micro Perf
• 10841962114919: Fibreplast Open View Hd + Shld 3.2mm Micro Perf
• 10841962114896: Fibreplast Open View Hd + Shld 3.2mm Micro Perf
• 10841962114858: Assure Open View Fibreplast 48 cm Hd+Shldr BoS Flap, 3.2 mm
• 10841962114834: Assure Open View Fibreplast 48 cm Hd+Shldr BoS Flap, 3.2 mm
• 10841962114766: Assure Open View Fibreplast 31 cm Hd+Neck BoS Flap, 3.2 mm
• 10841962114742: Assure Open View Fibreplast 31 cm Hd+Neck BoS Flap, 3.2 mm
• 10841962114490: Fibreplast Open View Split S-Frame 3.2mm
• 10841962114476: Fibreplast Open View Split S-Frame 3.2mm
• 10841962114469: Fibreplast Open View Slim Split Frame U-Frame Lng
• 10841962114445: Fibreplast Open View Slim Split Frame U-Frame Lng
• 10841962114438: Fibreplast Open View Spt Hd Only S-Frame
• 10841962114414: Fibreplast Open View Spt Hd Only S-Frame
• 10841962114346: Assure Open View Fibreplast 3 Point Mask
• 10841962114322: Assure Open View Fibreplast 3 Point Mask
• 10841962116234: Fibreplast Open View Slim Split-Frame U-Frame Lng.
• 10841962116210: Fibreplast Open View Slim Split-Frame U-Frame Lng.
• 10841962117934: Fibreplast Open View Spt Hd Only S-Frame, 3.2mm Micro Perf w/ Integrated Shim
• 10841962117910: Fibreplast Open View Spt Hd Only S-Frame, 3.2mm Micro Perf w/ Integrated Shim