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: Bone tap, reusable FDA UDI
Device Name: Tap, Single Lead, ø4.7mm FDA UDI
Model / Reference: P51-911-4700 FDA UDI
Description: Tap, Single Lead, ø4.7mm FDA UDI

Identifiers

Catalog Number: P51-911-4700 FDA UDI
Primary DI / UDI-DI: 00889795054531 FDA UDI
FDA Product Code: HWX FDA UDI
GMDN Term: Bone tap, 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

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: Bone tap, 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 Bone tap, reusable.

BIOSURE — Smith & Nephew, Inc. · Class I
NobelActive® — Nobel Biocare AG · Class I
CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
PressON™ — NEXUS SPINE, L.L.C. · Class I
Insite — TORNIER, INC. · Class I
ReLine — Nuvasive, Inc. · Class I
Mariner MIS — SeaSpine Orthopedics Corporation · Class I
Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI 62660c31-ee34-423f-bcc5-9d3d86a9e20c 34 fields · synced Jun 1, 2026