Identity
- Trade Name
- 32Ch Head Coil FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 1H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included. FDA UDI
- Model / Reference
- MC 3003G-32R FDA UDI
- Description
- The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 1H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857371006007 FDA UDI
- 510(k) Number
- K072931 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- MRI system coil, radio-frequency 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
Yes
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
Yes
FDA UDI
Category: MRI system coil, radio-frequency
32Ch Head Coil by Mr Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Mr Instruments, Inc.
Sources (1)
- FDA UDI 4287da1d-1dc4-462c-9839-bd869ddd88f9 34 fields · synced May 30, 2026