Baby Gorilla®/Gorilla® Plating System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Baby Gorilla®/Gorilla® Plating System FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: Drill Guide, EZ Cone Ø3.5mm, Long FDA UDI
Model / Reference: P51-901-5035 FDA UDI
Description: Drill Guide, EZ Cone Ø3.5mm, Long FDA UDI

Identifiers

Catalog Number: P51-901-5035 FDA UDI
Primary DI / UDI-DI: 00889795111180 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, reusable.

ORTHOFIX — Orthofix, Inc. · Class I
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Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
Truliant — Exactech, Inc. · Class II
Vantage — Exactech, Inc. · Class II
Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · 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 1d21e46d-3f6c-4100-9b1d-0b8b3eeebd1c 34 fields · synced Jun 1, 2026