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Disposable Radiolucent Skull Pins (3 Pcs)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 18910-01A
by Brainlab SE
Identity
- Trade Name
- Disposable Radiolucent Skull Pins (3 Pcs) EUDAMEDFDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- Disposable Radiolucent Skull Pins EUDAMED
- Model / Reference
- 18910-01A EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 18910-01A FDA UDI
- Primary DI / UDI-DI
- 04056481004767 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481004767 EUDAMED
- 510(k) Number
- K122225 FDA UDI
- FDA Product Code
- HBL FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES 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
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
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 Radiolucent Skull Pins (3 Pcs) by Brainlab SE — Class IIa — 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-04056481004767 | 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 ddcaeca7-b7f4-45f9-ab9e-b327369625da 61 fields · synced Jul 17, 2026
- FDA UDI 1ce84d1c-f407-4436-82cc-94581b9bb80d 35 fields · synced May 30, 2026