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Owl

FDA UDI

Class II (US FDA UDI)

by Diros Technology, Inc.

Identity

Trade Name
OWL FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe cannula, reusable FDA UDI
Device Name
OWL RE-USABLE BLUNT CURVED RF INSULATED CANNULA, (20Ga) 15cm LONG, 10MM BARE TIP FDA UDI
Model / Reference
466-004/150/10-BRC-S FDA UDI
Description
OWL RE-USABLE BLUNT CURVED RF INSULATED CANNULA, (20Ga) 15cm LONG, 10MM BARE TIP FDA UDI

Identifiers

Catalog Number
466-004/150/10-BRC-S FDA UDI
Primary DI / UDI-DI
00825114001404 FDA UDI
510(k) Number
K010202 FDA UDI
FDA Product Code
GXI FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe cannula, reusable 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Percutaneous radio-frequency ablation probe cannula, reusable

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 cannula, reusable.

Cleared under the same submission

K010202 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diros Technology, Inc.

Sources (1)

  • FDA UDI 21b723b3-bce5-45de-ae46-615346ca44af 37 fields · synced Jun 8, 2026