Insight™ RT-4700-01

GUDID 10841962109939

Insight™ MR Overlay

Qfix

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• Primary Device ID: 10841962109939
• NIH Device Record Key: f38008f7-9011-4635-96d0-b6261b3c6a81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insight™
• Version Model Number: RT-4700-01
• Catalog Number: RT-4700-01
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962109939 [Primary]

FDA Product Code

• KXJ: Table, radiologic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-12-11
• Device Publish Date: 2016-09-13

On-Brand Devices [Insight™]

• 10841962109953: Insight™ MRI Bridge with Body Coil Holder
• 10841962119396: Insight™ MR Head Coil Holder, Siemens Free.Max
• 10841962119389: Insight™ MR Overlay Head and Shoulders, Siemens Free.Max
• 10841962109946: Insight™ MR Head Coil Holder
• 10841962109939: Insight™ MR Overlay