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: Cannulated surgical drill bit, single-use FDA UDI
Device Name: Morselizing Bone Graft Harvester, AO, 8mm FDA UDI
Model / Reference: P99-930-2108 FDA UDI
Description: Morselizing Bone Graft Harvester, AO, 8mm FDA UDI

Identifiers

Catalog Number: P99-930-2108 FDA UDI
Primary DI / UDI-DI: 00889795051844 FDA UDI
FDA Product Code: HWK FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use 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

MRI Safety

MR Unsafe FDA UDI

Category: Cannulated surgical drill bit, single-use

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

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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 e4b89c42-72c0-4d38-9919-0e50769d9bfd 34 fields · synced Jun 1, 2026