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Disposable Generic Ultrasound Adapter Band (size M) (3 Pcs)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 41860-45Model 41860-46
by Brainlab SE
Identity
- Trade Name
- DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS) EUDAMEDDISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS) FDA UDI
- Generic Name
- Neurosurgical ultrasound navigation system optical tracking unit FDA UDI
- Device Name
- DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS) EUDAMED
- Model / Reference
- 41860-46 EUDAMED41860-45 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144456 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481USAdapterBand3S EUDAMED
- 510(k) Number
- K192703 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Neurosurgical ultrasound navigation system optical tracking unit FDA UDI
Classification
- Device Class
- Class I 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
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
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
Yes
FDA UDI
Disposable Generic Ultrasound Adapter Band (size M) (3 Pcs) by Brainlab SE — Class I — 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 | 4056481USAdapterBand3S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 8a58816c-c2d0-41d3-899f-8f4c8ae4413f 61 fields · synced Oct 6, 2026
- FDA UDI 11241a76-c87f-4c65-96db-4c40b9083e32 33 fields · synced May 30, 2026