Identity
- Trade Name
- EMPIRE microIncision Needle Electrodes FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- EMPIRE ELECTRODE 1/16",STERILE, 2 PK FDA UDI
- Model / Reference
- TEE303 FDA UDI
- Description
- EMPIRE ELECTRODE 1/16",STERILE, 2 PK FDA UDI
Identifiers
- Catalog Number
- TEE303 FDA UDI
- Primary DI / UDI-DI
- 00841494102890 FDA UDI
- FDA Product Code
- JOS 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
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
EMPIRE microIncision Needle Electrodes by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Cynosure, LLC
Sources (1)
- FDA UDI 151d077b-7a19-4475-a57e-0aee98b2784f 34 fields · synced May 31, 2026