Identity
- Trade Name
- Focalist System FDA UDI
- Generic Name
- Ultrasound imaging system operator console FDA UDI
- Model / Reference
- C001-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850062065000 FDA UDI
- 510(k) Number
- K250524 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Ultrasound imaging system operator console FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Weight — 75 Kilogram FDA UDI
Category: Ultrasound imaging system operator console
Focalist System by Mendaera, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mendaera, Inc.
Sources (1)
- FDA UDI 15609849-d875-47f0-b2f6-d8a6de84ea88 36 fields · synced May 30, 2026