R3ACT Stabilization System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: R3ACT Stabilization System FDA UDI
Generic Name: Orthopaedic fixation implant alignment tool FDA UDI
Device Name: Ø2.8mm Drill Cone Guide FDA UDI
Model / Reference: P80-930-2800 FDA UDI
Description: Ø2.8mm Drill Cone Guide FDA UDI

Identifiers

Catalog Number: P80-930-2800 FDA UDI
Primary DI / UDI-DI: 00889795113726 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic fixation implant alignment tool

R3ACT Stabilization System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Paragon 28

Sources (1)

FDA UDI 8ba40588-c786-4487-9247-648797942cc4 34 fields · synced Jun 6, 2026