Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- MONOPOLAR CUT/COAGULATION RF-CURETTE WITH IRRIGATION AND SUCTION. INSULATED STAINLESS STEEL-REUSABLE, STANDARD STRAIGHT TIP, 4MM DIA., 5.5CM WORKING LENGTH, RIGHT SIDE SUCTION PORT, 21CM OVERALL LENGTH, DESIGN BY DR. GIANCARLO LUIGI FDA UDI
- Model / Reference
- 5189-LESDIC FDA UDI
- Description
- MONOPOLAR CUT/COAGULATION RF-CURETTE WITH IRRIGATION AND SUCTION. INSULATED STAINLESS STEEL-REUSABLE, STANDARD STRAIGHT TIP, 4MM DIA., 5.5CM WORKING LENGTH, RIGHT SIDE SUCTION PORT, 21CM OVERALL LENGTH, DESIGN BY DR. GIANCARLO LUIGI FDA UDI
Identifiers
- Catalog Number
- 5189-LESDIC FDA UDI
- Primary DI / UDI-DI
- 00842180136427 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, 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
Yes
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, monopolar, reusable
Elmed by Elmed Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.
- MediMax Tech — MEDIMAX TECH INC. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Electrode — SOPRO-COMEG GmbH · Class II
- Sklar® — Sklar Corporation · Class II
- PILLING — TELEFLEX INCORPORATED · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Electrode — SOPRO-COMEG GmbH · Class II
- Sklar® — Sklar Corporation · 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
- Elmed Incorporated
Sources (1)
- FDA UDI 7cf876f3-5009-4625-8754-2db765d5c383 35 fields · synced May 31, 2026