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40004 PercuNav Coaxial Needle Tracker, 17Gx16cm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989605428014
Identity
- Trade Name
- 40004 PercuNav Coaxial Needle Tracker, 17Gx16cm EUDAMED40004 PercuNav Coaxial Needle Tracker, 17G x 16 cm FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Philips PercuNav Coaxial Needle Tracker EUDAMED
- Model / Reference
- 989605428014 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838083004 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM435SZ EUDAMED
- FDA Product Code
- IYO FDA UDILLZ FDA UDIJAK FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.2050 FDA UDI892.1750 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
40004 PercuNav Coaxial Needle Tracker, 17Gx16cm by Philips Ultrasound LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM435SZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 35b4b7ed-1301-42d0-bb84-8c0b9c136c07 61 fields · synced Oct 6, 2026
- FDA UDI 89a4da26-f786-41a4-8867-cc9af592cdd9 32 fields · synced May 25, 2026