Identity
- Trade Name
- Invivo FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assemblies; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 LBS C-C Grid Immobilization Plates Sterilized; 3 LBS C-C Pillar Immobilization Plates Sterilized; 2 Biopsy Fiducial Markers; MRI Needle Sleeve 16G; Fiducial Marker Block; 2 Needle Block Holder. FDA UDI
- Model / Reference
- 9896-031-10735 FDA UDI
- Description
- BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assemblies; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 LBS C-C Grid Immobilization Plates Sterilized; 3 LBS C-C Pillar Immobilization Plates Sterilized; 2 Biopsy Fiducial Markers; MRI Needle Sleeve 16G; Fiducial Marker Block; 2 Needle Block Holder. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838115255 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI system coil, radio-frequency
Invivo by Philips DS North America LLC — 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
- Philips DS North America LLC
Sources (1)
- FDA UDI d4128aa2-fe8e-4f5a-b331-ebcda31a2492 34 fields · synced Jun 8, 2026