Identity
- Trade Name
- OWL FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use FDA UDI
- Device Name
- OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 5 CM CANNULA (THERMISTOR) FDA UDI
- Model / Reference
- D466-005 FDA UDI
- Description
- OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 5 CM CANNULA (THERMISTOR) FDA UDI
Identifiers
- Catalog Number
- D466-005 FDA UDI
- Primary DI / UDI-DI
- 00825114006249 FDA UDI
- 510(k) Number
- K110593 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4725 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
Owl by Diros Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use.
- Radiofrequency Single-Use Probe — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Epimed — EPIMED INTERNATIONAL, INC. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Epimed — MINTA MEDICAL LIMITED · Class II
- Epimed — MINTA MEDICAL LIMITED · Class II
- Nimbus Probe (Disposable) — Stratus Medical LLC · Class II
Cleared under the same submission
K110593 also covers:
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
- OWL — Diros Technology, Inc.
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 4b7bb937-dfe8-499b-bd61-39a36340f92d 37 fields · synced Jun 6, 2026