Monster Screw System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Monster Screw System FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: Drill Guide, 4.0mm FDA UDI
Model / Reference: P20-941-4000 FDA UDI
Description: Drill Guide, 4.0mm FDA UDI

Identifiers

Catalog Number: P20-941-4000 FDA UDI
Primary DI / UDI-DI: 00889795036148 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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical drill guide, reusable

Monster Screw 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 a1e43bd4-7712-41b7-b4e2-3a9241b8b0e1 34 fields · synced Jun 1, 2026