Identity
- Trade Name
- Needle Block Holder EUDAMEDInvivo KITS (Disposables) FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Biopsy Guidance EUDAMEDNeedle Block Holder FDA UDI
- Model / Reference
- 989603203543 EUDAMEDNeedle Block Holder FDA UDI
- Description
- Needle Block Holder FDA UDI
Identifiers
- Catalog Number
- 989603203543 FDA UDI
- Primary DI / UDI-DI
- 00884838073036 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838073036 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
Needle Block Holder 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 Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838073036 | Class I | 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 1171f95c-5b23-4b1d-95ad-82e666e87f33 61 fields · synced Jun 18, 2026
- FDA UDI 533592c5-0a5a-4f40-a977-3d15edc4e398 36 fields · synced May 30, 2026