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: Orthopaedic bone wire FDA UDI
Device Name: P28, K-wire, Ø2.9 x 200mm, Smooth, SS FDA UDI
Model / Reference: P99-192-2920 FDA UDI
Description: P28, K-wire, Ø2.9 x 200mm, Smooth, SS FDA UDI

Identifiers

Catalog Number: P99-192-2920 FDA UDI
Primary DI / UDI-DI: 00889795023414 FDA UDI
FDA Product Code: HXI FDA UDI
GMDN Term: Orthopaedic bone wire 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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic bone wire

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 Orthopaedic bone wire.

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De Soutter Medical — De Soutter Medical, Ltd. · Class I
SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
mahe medical GmbH — mahe medical gmbh · Class II
OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
gSource — GSOURCE, LLC. · Class II

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 3a9db7a0-d108-4f7c-8dd2-7ceb8b31720b 34 fields · synced May 31, 2026