AVTRAC MTP Revision System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: AVTRAC MTP Revision System FDA UDI
Generic Name: Bone-resection orthopaedic reamer, single-use FDA UDI
Device Name: AVITRAC™ Core, MTP Reamer, Ø13 mm, STERILE FDA UDI
Model / Reference: P01-901-1301-S FDA UDI
Description: AVITRAC™ Core, MTP Reamer, Ø13 mm, STERILE FDA UDI

Identifiers

Catalog Number: P01-901-1301-S FDA UDI
Primary DI / UDI-DI: 00889795097576 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Bone-resection orthopaedic reamer, single-use

AVTRAC MTP Revision System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone-resection orthopaedic reamer, single-use.

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PANTA® — Newdeal Sas · Class I
ACETABULAR REAMER EVO 2 Ti CUP D42 mm — HPF SRL · Class I
Arthrex® — Arthrex, Inc. · Class I
Tools - UFC — Trimed, INC. · Class I

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 8025ddb2-11bd-4f0f-9e91-fb2aae8cdf80 34 fields · synced Jun 8, 2026