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Disposable Trocar Insert Pedicle Access Needle (1 PC)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 55846-01
by Brainlab SE
Identity
- Trade Name
- Disposable Trocar Insert Pedicle Access Needle (1 PC) EUDAMEDDisposable Trocar Insert Pedicle Access Needle (1 pcs.) FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Disposable Trocar Insert Pedicle Access Needle EUDAMED
- Model / Reference
- 55846-01 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 55846-01 FDA UDI
- Primary DI / UDI-DI
- 04056481001018 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481SpinalToolVV EUDAMED
- 510(k) Number
- K183605 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- 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
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Disposable Trocar Insert Pedicle Access Needle (1 PC) by Brainlab SE — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 4056481SpinalToolVV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED b84b7615-0194-4789-9362-762542981dd8 61 fields · synced Jul 9, 2026
- FDA UDI dab75a73-f746-4041-a47f-c71b10d55655 35 fields · synced May 30, 2026