Identity
- Trade Name
- Millennium FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- Micro Tip Electrode, 2mm straight pin point tip, shaft size 3mm (3/32"), straight 6cm needle shaft, 2 1/2" shaft length FDA UDI
- Model / Reference
- 72-590104B FDA UDI
- Description
- Micro Tip Electrode, 2mm straight pin point tip, shaft size 3mm (3/32"), straight 6cm needle shaft, 2 1/2" shaft length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776395025 FDA UDI
- 510(k) Number
- K974793 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, reusable
Millennium by AVALIGN TECHNOLOGIES, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, reusable.
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Cameron-Miller — Cameron-Miller, Inc. · Class II
- MicroFrance® — Integra Microfrance · Class II
- ELMED INCORPORATED — ELMED INCORPORATED · Class II
- Bipolar Forceps — BLACK & BLACK SURGICAL, INC. · Class II
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
- Cameron-Miller — Cameron-Miller, Inc. · Class II
Cleared under the same submission
K974793 also covers:
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- Active Cord Reusable Bovie — Micro-tech Usa
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
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI dceb1690-a304-4f43-9f42-e5f3590a6d27 35 fields · synced Jun 1, 2026