FlexLock™ RT-4800-FS

GUDID 10841962111086

FlexLock™ Foot Support

Qfix

Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner Radiological general body-part positioner

• Primary Device ID: 10841962111086
• NIH Device Record Key: ee0f7f85-bad0-48fd-abae-83e313d11fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexLock™
• Version Model Number: RT-4800-FS
• Catalog Number: RT-4800-FS
• 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: +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 Identifiers

Device Issuing Agency	Device ID
GS1	10841962111086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060671

FDA Product Code

• JAI: Couch, radiation therapy, powered

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: 2020-10-23
• Device Publish Date: 2020-10-15

On-Brand Devices [FlexLock™]

• 10841962111086: FlexLock™ Foot Support
• 10841962111048: FlexLock™ Knee Support