Identity
- Trade Name
- Ultrasonic Generator FDA UDI
- Generic Name
- Ultrasonic surgical system generator FDA UDI
- Model / Reference
- USG-400 FDA UDI
Identifiers
- Catalog Number
- N5428140 FDA UDI
- Primary DI / UDI-DI
- 04953170386817 FDA UDI
- 510(k) Number
- K172691 FDA UDI
- FDA Product Code
- LFL FDA UDIGEI FDA UDI
- GMDN Term
- Ultrasonic surgical system generator FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 878.4400 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: Ultrasonic surgical system generator
Ultrasonic Generator by Olympus Medical Systems Corporation — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI a65e0f7c-3390-404c-8cf2-52386fa61082 35 fields · synced Jun 8, 2026