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Grid Immobilization Plate LBS C-C
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989603209063
Identity
- Trade Name
- Grid Immobilization Plate LBS C-C EUDAMEDInvivo KITS (Disposables) FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Biopsy Guidance EUDAMEDGrid Immobilization Plate LBS C-C FDA UDI
- Model / Reference
- 989603209063 EUDAMEDGrid Immobilization Plate LBS C-C FDA UDI
- Description
- Grid Immobilization Plate LBS C-C FDA UDI
Identifiers
- Catalog Number
- 989603209063 FDA UDI
- Primary DI / UDI-DI
- 00884838073098 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838073098 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
Grid Immobilization Plate LBS C-C 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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-00884838073098 | Class I | No Longer Active |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 c9231490-eb2b-4ee0-a2a1-2aa1f10b4b7b 61 fields · synced Jul 17, 2026
- FDA UDI a6066dca-47c7-493d-b809-42e030084f12 36 fields · synced May 30, 2026