Monkey Bars™ Pin to Bar External Fixation System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Monkey Bars™ Pin to Bar External Fixation System FDA UDI
Generic Name: Cannulated surgical drill bit, reusable FDA UDI
Device Name: 4.0mm x 200mm Calibrated Step Drill FDA UDI
Model / Reference: P47-100-4020 FDA UDI
Description: 4.0mm x 200mm Calibrated Step Drill FDA UDI

Identifiers

Catalog Number: P47-100-4020 FDA UDI
Primary DI / UDI-DI: 00889795114860 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Cannulated surgical drill bit, reusable 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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Cannulated surgical drill bit, reusable

Monkey Bars™ Pin to Bar External Fixation System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cannulated surgical drill bit, reusable.

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Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
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BIXCUT — Stryker Corp. · Class I
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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 0224d48e-728c-4ae4-a346-cf6dc30a12bc 34 fields · synced Jun 1, 2026