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 depth gauge, reusable FDA UDI
Device Name: Depth Gauge, Wire Measuring, R3LEASE FDA UDI
Model / Reference: P80-950-0080 FDA UDI
Description: Depth Gauge, Wire Measuring, R3LEASE FDA UDI

Identifiers

Catalog Number: P80-950-0080 FDA UDI
Primary DI / UDI-DI: 00889795049469 FDA UDI
FDA Product Code: HTJ FDA UDI
GMDN Term: Surgical depth gauge, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4300 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 depth gauge, 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 depth gauge, reusable.

Depth Gauge — I.T.S. GmbH · Class I
FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Trigen — Smith & Nephew, Inc. · Class I
HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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 86504825-d797-4b94-b197-f1893e00b211 34 fields · synced May 31, 2026