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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, single-use FDA UDI
Device Name
OWL STERILE SINGLE USE DISPOSABLE TRIDENT RF INSULATED CANNULA, 18GA, 10MM BARE TIP FOR 10CM PROBE FDA UDI
Model / Reference
DTR-018/100/10 FDA UDI
Description
OWL STERILE SINGLE USE DISPOSABLE TRIDENT RF INSULATED CANNULA, 18GA, 10MM BARE TIP FOR 10CM PROBE FDA UDI

Identifiers

Catalog Number
DTR-018/100/10 FDA UDI
Primary DI / UDI-DI
00825114004658 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

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
MRI Safety
MR Unsafe FDA UDI

Category: Percutaneous radio-frequency ablation probe cannula, 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 cannula, single-use.

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 ffa7df9f-b963-45a5-9f63-dfee586c2ca8 36 fields · synced Jun 8, 2026