Identity
- Trade Name
- UNIVERSAL PLUS FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING - SUCTION/IRRIGATION, 5MM X 27CM NEEDLE FDA UDI
- Model / Reference
- 60-5274-927 FDA UDI
- Description
- UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING - SUCTION/IRRIGATION, 5MM X 27CM NEEDLE FDA UDI
Identifiers
- Catalog Number
- 60-5274-927 FDA UDI
- Primary DI / UDI-DI
- 30653405010818 FDA UDI
- 510(k) Number
- K952204 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 27 Centimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Universal Plus by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K952204 also covers:
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
- Conmed Corporation
Sources (1)
- FDA UDI e3191d00-d479-4aa9-bc88-41e0c9e3f89a 39 fields · synced May 31, 2026