Identity
- Trade Name
- Pillar Immobilization Plate EUDAMEDInvivo KITS (Disposables) FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Biopsy Guidance EUDAMEDPillar Immobilization Plate FDA UDI
- Model / Reference
- 989603209103 EUDAMEDPillar Immobilization Plate FDA UDI
- Description
- Pillar Immobilization Plate FDA UDI
Identifiers
- Catalog Number
- 989603209103 FDA UDI
- Primary DI / UDI-DI
- 00884838073135 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838073135 EUDAMED
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
MR Conditional FDA UDI
Pillar Immobilization Plate by Invivo Corporation — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838073135 | Class I | No Longer Active |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 9a978c45-67e1-43b7-8274-fa94b71142c9 61 fields · synced Jul 29, 2026
- FDA UDI 68cd19b9-94c7-4262-b9c4-281376c67aae 36 fields · synced May 30, 2026