Identity
- Trade Name
- SONICBEAT Transducer FDA UDI
- Generic Name
- Ultrasonic surgical system transducer FDA UDI
- Model / Reference
- TD-SB400 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170306808 FDA UDI
- 510(k) Number
- K211838 FDA UDI
- FDA Product Code
- GEI FDA UDIKNS FDA UDILFL FDA UDI
- GMDN Term
- Ultrasonic surgical system transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI876.4300 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
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic surgical system transducer
SONICBEAT Transducer by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic surgical system transducer.
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- THUNDERBEAT Transducer — Olympus Medical Systems Corporation · Class II
- SonoSurg Transducer — Olympus Medical Systems Corporation · U
Cleared under the same submission
K211838 also covers:
- SONICBEAT 5 mm, 10 cm, Inline Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 10 cm, Inline Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 20 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT Footswitch Connector — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S — Olympus Medical Systems Corporation
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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 7eeb39ca-8d48-4d4b-9b37-8d5f791209cd 34 fields · synced May 30, 2026