iTX Extremity 18 Flare

GUDID 04056869231204

Siemens Shenzhen Magnetic Resonance Ltd.

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• Primary Device ID: 04056869231204
• NIH Device Record Key: bd54bb7d-2352-4243-8d35-d22310a10710
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTX Extremity 18 Flare
• Version Model Number: 11293128
• Company DUNS: 544891302
• Company Name: Siemens Shenzhen Magnetic Resonance Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869231204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183221

FDA Product Code

• MOS: Coil, magnetic resonance, specialty

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: 2021-08-09
• Device Publish Date: 2021-07-30

Devices Manufactured by Siemens Shenzhen Magnetic Resonance Ltd.

• 04056869281759 - MAGNETOM Free.Max: 2022-09-09
• 04056869281766 - MAGNETOM Free.Star: 2022-09-09
• 04056869281773 - MAGNETOM Free.Star: 2022-09-09
• 04056869281926 - Contour M Coil Set: 2022-09-09
• 04056869281742 - MAGNETOM Free.Max: 2021-08-10 MRI Scanner
• 04056869281858 - Head/Neck Coil: 2021-08-10
• 04056869281896 - Head/Neck Coil Set: 2021-08-10
• 04056869281933 - Spine Coil: 2021-08-10