Identity
- Trade Name
- Thermalite Disposable TCU Electrode FDA UDI
- Generic Name
- Electrocautery system electrode FDA UDI
- Device Name
- THERMALITE DISPOSABLE TCU TIPS, ANGLED LOOP,BOX/10. Medical Device. FDA UDI
- Model / Reference
- 212 FDA UDI
- Description
- THERMALITE DISPOSABLE TCU TIPS, ANGLED LOOP,BOX/10. Medical Device. FDA UDI
Identifiers
- Catalog Number
- 212 FDA UDI
- Primary DI / UDI-DI
- 10609960001002 FDA UDI
- FDA Product Code
- HQO FDA UDI
- GMDN Term
- Electrocautery system electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4115 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrocautery system electrode
Thermalite Disposable TCU Electrode by Dermatologic Lab And Supply, Inc. — 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
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Carrera Loop Electrodes — GYNEX CORPORATION · Class II
- MediMax Tech — MEDIMAX TECH INC. · 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
- Dermatologic Lab And Supply, Inc.
Sources (1)
- FDA UDI a2c322a1-1ac0-4343-9a30-b63d1a3321c4 34 fields · synced May 31, 2026