Identity
- Trade Name
- OWL FDA UDI
- Generic Name
- Nerve-locating anaesthesia needle FDA UDI
- Device Name
- OWL STERILE SINGLE USE DISPOSABLE DRC CANNULA (22GA.), 100MM LONG FDA UDI
- Model / Reference
- DRC-022/100 FDA UDI
- Description
- OWL STERILE SINGLE USE DISPOSABLE DRC CANNULA (22GA.), 100MM LONG FDA UDI
Identifiers
- Catalog Number
- DRC-022/100 FDA UDI
- Primary DI / UDI-DI
- 00825114002586 FDA UDI
- 510(k) Number
- K102566 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Nerve-locating anaesthesia needle 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: Nerve-locating anaesthesia needle
Owl by Diros Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nerve-locating anaesthesia needle.
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- UNIPLEX® NANOLINE — Pajunk GmbH Medizintechnologie · Class II
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- SonoPlex® II Facet S NRFit — Pajunk GmbH Medizintechnologie · Class II
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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
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 93e9e8d7-325d-4cf8-8b86-8da76f9705db 37 fields · synced May 31, 2026