Fibreplast™ Micro Perf™ Assure™ Open View RT-1778KSDF

GUDID 10841962105320

Fibreplast Open View Hd +Shldr 2.4mm Micro Perf

Qfix

Patient positioning thermoplastic mould material

• Primary Device ID: 10841962105320
• NIH Device Record Key: 6513f8a4-d048-4146-969e-d899d524b70a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fibreplast™ Micro Perf™ Assure™ Open View
• Version Model Number: RT-1778KSDF
• Catalog Number: RT-1778KSDF
• 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: false
• 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

Device Dimensions

• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter
• Depth: 2.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962105320 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-18
• Device Publish Date: 2016-12-22

On-Brand Devices [Fibreplast™ Micro Perf™ Assure™ Open View]

• 10841962105337: Fibreplast Open View Hd +Shldr 2.4mm Micro Perf
• 10841962105320: Fibreplast Open View Hd +Shldr 2.4mm Micro Perf