Paratrooper™ Plantar Plate Repair System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name: Paratrooper™ Plantar Plate Repair System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Monster Bite Driver, Disposable Handle FDA UDI
Model / Reference: P13-905-0001 FDA UDI
Description: Monster Bite Driver, Disposable Handle FDA UDI

Identifiers

Catalog Number: P13-905-0001 FDA UDI
Primary DI / UDI-DI: 00889795106230 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

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: Surgical screwdriver, reusable

Paratrooper™ Plantar Plate Repair System by Paragon 28 — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI d694dfb6-fa98-4413-b535-e076ba6a2ac0 34 fields · synced Jun 8, 2026