Identity
- Trade Name
- Symmetry Olsen FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Model / Reference
- 41300 FDA UDI
Identifiers
- Catalog Number
- 41300 FDA UDI
- Primary DI / UDI-DI
- 00841785106767 FDA UDI
- 510(k) Number
- K130669 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
Symmetry Olsen by Olsen Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, reusable.
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- ELMED INCORPORATED — ELMED INCORPORATED · Class II
- Electrode — SOPRO-COMEG GmbH · Class II
- Sklar® — Sklar Corporation · Class II
- PILLING — TELEFLEX INCORPORATED · Class II
- ELMED INCORPORATED — ELMED INCORPORATED · Class II
Cleared under the same submission
K130669 also covers:
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
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
- Olsen Medical
Sources (1)
- FDA UDI 4d732100-db48-4ab9-891c-5c7f1d73ac2d 34 fields · synced Jun 8, 2026