Identity
- Trade Name
- Key Surgical Electro Lube FDA UDI
- Generic Name
- Electrosurgical electrode lubricant FDA UDI
- Device Name
- Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking. FDA UDI
- Model / Reference
- EL-101 FDA UDI
- Description
- Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking. FDA UDI
Identifiers
- Catalog Number
- EL101 FDA UDI
- Primary DI / UDI-DI
- 00849771037873 FDA UDI
- 510(k) Number
- K033880 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical electrode lubricant 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
Dimensions & Sizes
- Size
- Total Volume — 4 Milliliter FDA UDI
Key Surgical Electro Lube by Key Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K033880 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
- Key Surgical, LLC
Sources (1)
- FDA UDI 4a7cc300-dee2-45ab-b483-4daaddb0fa8d 38 fields · synced May 29, 2026