Extremity XL MR Coil Kit

GUDID 04056869049595

Contains Medical Device Mat. 8635570 (GTIN:04056869038810)

Siemens Shenzhen Magnetic Resonance Ltd.

Full-body MRI system, permanent magnet

• Primary Device ID: 04056869049595
• NIH Device Record Key: a4d73a56-63f7-48a5-9a44-4e3dc5a5fa3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extremity XL MR Coil Kit
• Version Model Number: 10019204
• 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: 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	04056869049595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041111

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2018-07-06
• Device Publish Date: 2016-09-24

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