TruDi Probe

FDA UDI

Class II (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name: TruDi Probe FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: TruDI Probe 0-Degree - 5PK FDA UDI
Model / Reference: TDP0005 FDA UDI
Description: TruDI Probe 0-Degree - 5PK FDA UDI

Identifiers

Catalog Number: TDP0005 FDA UDI
Primary DI / UDI-DI: 10705031464193 FDA UDI
510(k) Number: K193453 FDA UDI
FDA Product Code: PGW FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Multi-purpose stereotactic surgery system

TruDi Probe by Acclarent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose stereotactic surgery system.

PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
PEEK INSTRUMENT ADAPTOR Ø4.6MM — MEDTECH LLC · Class II
Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa

Cleared under the same submission

K193453 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Acclarent, Inc.

Sources (1)

FDA UDI bd3c4017-9712-4489-a956-7f68f3339d22 37 fields · synced May 30, 2026