Identity
- Trade Name
- Premier FDA UDI
- Generic Name
- Electrocautery system electrode FDA UDI
- Device Name
- TRUCONE ELECTRODE 18MM X 12MM 5-PK FDA UDI
- Model / Reference
- 9006110 FDA UDI
- Description
- TRUCONE ELECTRODE 18MM X 12MM 5-PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- D6919006110 FDA UDI
- 510(k) Number
- K002042 FDA UDI
- FDA Product Code
- HGI FDA UDI
- GMDN Term
- Electrocautery system electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4120 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocautery system electrode
Premier by Premier Dental Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocautery system electrode.
- Ball Electrodes — GYNEX CORPORATION · Class II
- Carrera Loop Electrodes — GYNEX CORPORATION · Class II
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class II
- Carrera Loop Electrodes — GYNEX CORPORATION · Class II
- Geiger Reusable TCU Electrode — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
- Geiger Reusable TCU Electrode — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
- Geiger Reusable TCU Electrode — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class II
Cleared under the same submission
K002042 also covers:
- Premier — PREMIER DENTAL PRODUCTS COMPANY
- Premier — PREMIER DENTAL PRODUCTS COMPANY
- Premier — PREMIER DENTAL PRODUCTS COMPANY
- Premier — PREMIER DENTAL PRODUCTS COMPANY
- Premier — PREMIER DENTAL PRODUCTS COMPANY
- Premier — PREMIER DENTAL PRODUCTS COMPANY
- Premier — PREMIER DENTAL PRODUCTS COMPANY
- Premier — PREMIER DENTAL PRODUCTS COMPANY
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
- Premier Dental Products Company
Sources (1)
- FDA UDI f8dc05f2-d6e2-4600-97ca-2800e347c3d6 34 fields · synced May 30, 2026