Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, HARDY BAYONET, 10 3/4" (25.5CM) INSULATED, STRAIGHT TIP (*SPECIFY TIP SIZE) FDA UDI
- Model / Reference
- 5990-10* FDA UDI
- Description
- ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, HARDY BAYONET, 10 3/4" (25.5CM) INSULATED, STRAIGHT TIP (*SPECIFY TIP SIZE) FDA UDI
Identifiers
- Catalog Number
- 5990-10* FDA UDI
- Primary DI / UDI-DI
- 00842180141230 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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 7f44b8ef-ae97-401b-a84c-6796b75d8760 35 fields · synced May 31, 2026