Identity
- Trade Name
- Flex Large 8 Coil Set 1.5T FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Model / Reference
- 11293133 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869231112 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body MRI system, superconducting magnet
Flex Large 8 Coil Set 1.5T by Siemens Shenzhen Magnetic Resonance Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Full-body MRI system, superconducting magnet.
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- Head/Neck 20 MR Coil 1.5T — Siemens Healthcare · Class II
- Head 32 MR Coil Set 3T 098 — Siemens Healthcare · Class II
- Flex large 4 MR coil set 3T — Siemens Healthcare · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Shenzhen Magnetic Resonance Ltd.
Sources (1)
- FDA UDI be4d2675-80d2-41ac-bf3c-ce6c641002fe 33 fields · synced May 30, 2026