Identity
- Trade Name
- BREAST GRID (USER STERILIZED) EUDAMEDInvivo FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Breast Biopsy Guidance Devices EUDAMEDBiopsy Grid (User-sterilized) FDA UDI
- Model / Reference
- 989603214223 EUDAMEDBiopsy Grid Package (User-sterilized) FDA UDI
- Description
- Biopsy Grid (User-sterilized) FDA UDI
Identifiers
- Catalog Number
- 989603214223 FDA UDI
- Primary DI / UDI-DI
- 00884838083615 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM421SN EUDAMED
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Breast Grid (user Sterilized) by Invivo Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM421SN | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invivo Corporation
- EUDAMED SRN
- US-MF-000002284
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 5a6b6fca-00e4-4735-9bf4-0522f6191e65 61 fields · synced Oct 5, 2026
- FDA UDI 98d2d8d2-e2fd-4f35-830c-e91b786d305e 36 fields · synced May 30, 2026