DORO LUCENT® Sterile Disposable Skull Pins, Adult (3 pcs)
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- DORO LUCENT® Sterile Disposable Skull Pins, Adult (3 pcs) EUDAMEDDORO Lucent® Disposable Skull Pins FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- Sterile Disposable Skull Pin EUDAMEDDORO Lucent® Disposable Skull Pins, Adult (sterile, 3pcs) FDA UDI
- Model / Reference
- 1106.003 EUDAMEDFDA UDI
- Description
- DORO Lucent® Disposable Skull Pins, Adult (sterile, 3pcs) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435517789 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA0601YS EUDAMED
- Unit of Use DI
- 04250435545645 EUDAMED
- 510(k) Number
- K191740 FDA UDI
- FDA Product Code
- HBL FDA UDI
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Skull clamp FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4460 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Orthopaedic trocar blade, reusable
DORO LUCENT® Sterile Disposable Skull Pins, Adult (3 pcs) by Black Forest Medical GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504355PA0601YS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Black Forest Medical GmbH
- EUDAMED SRN
- DE-MF-000005752
Sources (2)
- EUDAMED 40d8a467-abbc-4581-8d0e-eae36214dde9 61 fields · synced Jul 8, 2026
- FDA UDI 0b73ae31-d333-46b1-9a27-41d60d55fd71 34 fields · synced May 29, 2026