Identity
- Trade Name
- EkoSonic® FDA UDI
- Generic Name
- Ultrasound thrombolysis system control unit FDA UDI
- Device Name
- The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors parameters during operation via the CIC. The Control Unit also provides the user interface for operator control. The EkoSonic® Control Unit is intended exclusively for use with the EkoSonic® Device. FDA UDI
- Model / Reference
- 600-30000 FDA UDI
- Description
- The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors parameters during operation via the CIC. The Control Unit also provides the user interface for operator control. The EkoSonic® Control Unit is intended exclusively for use with the EkoSonic® Device. FDA UDI
Identifiers
- Catalog Number
- 600-30000 FDA UDI
- Primary DI / UDI-DI
- 00858593006493 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Ultrasound thrombolysis system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 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: Ultrasound thrombolysis system control unit
EkoSonic® by Ekos Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound thrombolysis system control unit.
- EKOS™ — Boston Scientific · Class II
- Shockwave Medical IVL Generator and Connector Cable — SHOCKWAVE MEDICAL, INC. · Class II
- EKOS™ — Boston Scientific · Class II
- EKOS™ — Boston Scientific · Class II
- EKOS™ — Boston Scientific · Class II
- EKOS™ — Boston Scientific · Class II
- EKOS™ — Boston Scientific · Class II
- Lithoplasty® — SHOCKWAVE MEDICAL, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ekos Corporation
Sources (1)
- FDA UDI 0e31ace7-8d0b-48e4-b0d6-1534639e9914 36 fields · synced May 30, 2026