← Back to catalogue
DORO® Reusable Skull Pin Titanium, Pediatric (3 pcs)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3004-50
Identity
- Trade Name
- DORO® Reusable Skull Pin Titanium, Pediatric (3 pcs) EUDAMEDDORO® Reusable Skull Pins FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- Reusable Skull Pin EUDAMEDDORO® Reusable Skull Pin Titanium, Pediatric (3 pcs) FDA UDI
- Model / Reference
- 3004-50 EUDAMEDFDA UDI
- Description
- DORO® Reusable Skull Pin Titanium, Pediatric (3 pcs) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435508435 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA0602YU EUDAMED
- Direct Marketing DI
- 04250435508435 EUDAMED
- 510(k) Number
- K001808 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic trocar blade, reusable
DORO® Reusable Skull Pin Titanium, Pediatric (3 pcs) by Black Forest Medical GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Orthopaedic trocar blade, reusable.
- Trauma Fixation Systems — Biomet Orthopedics, Inc. · Class I
- LEVEL ONE TRANSBUCCAL — KLS-Martin L.P. · Class I
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I
- Adapterkabel Touchproof für ALM Tube — inomed Medizintechnik GmbH · Class I
- EBA ONE — Citieffe · Class II
- Tympanon-Elektrode mit 1, 5mm Sicherheitsstecker — inomed Medizintechnik GmbH · Class I
- ARTHROLUTION — Richard Wolf GmbH · Class I
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I
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 | 42504355PA0602YU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Black Forest Medical GmbH
- EUDAMED SRN
- DE-MF-000005752
Sources (2)
- EUDAMED 7e66ff97-e303-4b5b-978d-c383b0c034cd 61 fields · synced Jul 9, 2026
- FDA UDI 71d00e29-a488-4c39-a6f2-18784e4b5193 34 fields · synced May 27, 2026