Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- ELMED ESU 400 DIGITAL - GENERATION 2 ELECTROSURGICAL UNIT, FEATURING: MONOPOLAR AND BIPOLAR CUT AND COAGULATION, DIGITAL TOUCH SCREEN SELECTION AND MULTI-SCREEN DISPLAY, SMART-O-MATIC AUTOMATIC OUTPUT COMPENSATION FOR ALL ELECTRODES AND TISSUE CONDITION, SAFETY PATIENT RETURN ELECTRODE CIRCUIT. FDA UDI
- Model / Reference
- 5760 FDA UDI
- Description
- ELMED ESU 400 DIGITAL - GENERATION 2 ELECTROSURGICAL UNIT, FEATURING: MONOPOLAR AND BIPOLAR CUT AND COAGULATION, DIGITAL TOUCH SCREEN SELECTION AND MULTI-SCREEN DISPLAY, SMART-O-MATIC AUTOMATIC OUTPUT COMPENSATION FOR ALL ELECTRODES AND TISSUE CONDITION, SAFETY PATIENT RETURN ELECTRODE CIRCUIT. FDA UDI
Identifiers
- Catalog Number
- 5760 FDA UDI
- Primary DI / UDI-DI
- 00842180137004 FDA UDI
- FDA Product Code
- BWA FDA UDI
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class II 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system generator
Elmed by Elmed Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Elmed Incorporated
Sources (1)
- FDA UDI fab10af9-e1bf-4bb9-a3f0-b83d9b4f3bf1 35 fields · synced May 30, 2026