Identity
- Trade Name
- ultrasonic transducer FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Model / Reference
- P7-3MQ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413835481 FDA UDI
- 510(k) Number
- K250214 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held 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
Category: Extracorporeal ultrasound imaging transducer, hand-held
ultrasonic transducer by Edan Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K250214 also covers:
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Diagnostic Ultrasound System — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- Needle Guide Bracket Kit — Edan Instruments, Inc.
- ultrasonic transducer — Edan Instruments, Inc.
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
- Edan Instruments, Inc.
Sources (1)
- FDA UDI 1abea309-952b-47b4-a613-4a80757f9b77 33 fields · synced Jun 1, 2026