Identity
- Trade Name
- OWL FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
- Device Name
- OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (20GA.), 150MM LONG, 5MM BARE TIP FDA UDI
- Model / Reference
- DHC-020/150/5 FDA UDI
- Description
- OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (20GA.), 150MM LONG, 5MM BARE TIP FDA UDI
Identifiers
- Catalog Number
- DHC-020/150/5 FDA UDI
- Primary DI / UDI-DI
- 00825114002111 FDA UDI
- 510(k) Number
- K102566 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe cannula, 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Percutaneous radio-frequency ablation probe cannula, single-use
The OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (20GA.), 150MM LONG, 5MM BARE TIP is a premium medical device designed for safe and effective treatment of chronic pain in patients. This single-use device is available in various diameters and distal tip lengths/configurations, making it suitable for implantable applications or as an inject-aspiration cannula.
Similar devices
Also classified as Percutaneous radio-frequency ablation probe cannula, single-use.
- RadiOpaque Radiofrequency Cannula — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- RadiOpaque Radiofrequency Cannula — Avanos Medical, Inc. · Class II
- LCCS — Lccs Products Limited · Class II
- CannulaCRF — Cambridge Interventional LLC · Class II
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC · Class II
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC · Class II
- Halyard — Avanos Medical, Inc. · Class II
Cleared under the same submission
K102566 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.
- OWL — Diros Technology, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Diros Technology, Inc.
Sources (1)
- FDA UDI bfbc6705-434b-47f2-b9cb-e432d0e5a70b 37 fields · synced Jul 6, 2026