Identity
- Trade Name
- OWL FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- OWL Radio Frequency RF Lesion Generator FDA UDI
- Model / Reference
- URF-3AP FDA UDI
- Description
- OWL Radio Frequency RF Lesion Generator FDA UDI
Identifiers
- Catalog Number
- 653-100 FDA UDI
- Primary DI / UDI-DI
- 00825114000018 FDA UDI
- 510(k) Number
- K093185 FDA UDI
- FDA Product Code
- GXD FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4400 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Percutaneous radio-frequency ablation system generator
Owl by Diros Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K093185 also covers:
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
- Diros Technology, Inc.
Sources (1)
- FDA UDI ee3a9087-963b-4316-a25c-60151fa0a618 36 fields · synced Jun 1, 2026