Precision MIS Bunion System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Precision MIS Bunion System FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.5 Screw FDA UDI
Model / Reference: P27-943-0035 FDA UDI
Description: Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.5 Screw FDA UDI

Identifiers

Catalog Number: P27-943-0035 FDA UDI
Primary DI / UDI-DI: 00889795132871 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Surgical drill guide, reusable 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

MRI Safety

MR Conditional FDA UDI

Category: Surgical drill guide, reusable

Precision MIS Bunion 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 2bd5b612-e2b5-4ec9-971d-99d8b3e7108b 34 fields · synced Jun 1, 2026