3.0T HD T/R Quad Extremity Coil (flat base)
by Philips Medical Systems Nederland B.V.
Ref 300007290661
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0884838BM915TL 00884838108851 | Date16 Jan 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00884838108851 | Date31 Mar 2022 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- 3.0T HD T/R Quad Extremity Coil (flat base) EUDAMEDDunlee Sentinelle GUDID
- Generic Name
- MRI system coil, radio-frequency
- Device Name
- GE TxRx Coil PMS
- Model / Ref / Catalog
- 300007290661, 3.0T HD T/R Quad Extremity Coil (flat base)
- Primary DI / UDI-DI
- 00884838108851
- Basic UDI-DI
- 0884838BM915TL
- Direct Marketing DI
- 00884838108851
- FDA Product Code
- MOS
- EMDN Code
- Z1105018001, Z1105018002, Z1105018099
- GMDN Term
- MRI system coil, radio-frequency
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1000
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 300007290661 | 3.0T HD T/R Quad Extremity Coil (flat base) |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- NL-MF-000001489
Other devices from Philips Medical Systems Nederland B.V.
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Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No