TruFit 2.0

FDA UDI

Class I (US FDA UDI)

by Ortho Technology, Inc.

Identity

Trade Name: TruFit 2.0 FDA UDI
Generic Name: Orthodontic tube FDA UDI
Device Name: TruFit™2.0 .018 R UL6 CONV CBT HG-GIN -10T 10DO WLD (10PK) FDA UDI
Model / Reference: 490-11-2671 FDA UDI
Description: TruFit™2.0 .018 R UL6 CONV CBT HG-GIN -10T 10DO WLD (10PK) FDA UDI

Identifiers

Primary DI / UDI-DI: 00190730033239 FDA UDI
FDA Product Code: DZD FDA UDI
GMDN Term: Orthodontic tube FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic tube

TruFit 2.0 by Ortho Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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V-Slot — ASTAR ORTHODONTICS INC. · Class IIa

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 I	Pending data

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Manufacturer

Manufacturer: Ortho Technology, Inc.

Sources (1)

FDA UDI dd74c866-01c8-4abf-958b-01f1a3c1b9c9 33 fields · synced Jun 1, 2026