HammerTube System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: HammerTube System FDA UDI
Generic Name: Surgical countersink, reusable FDA UDI
Device Name: Bone Planer, 8mm (Patent Pending) FDA UDI
Model / Reference: P40-900-0801 FDA UDI
Description: Bone Planer, 8mm (Patent Pending) FDA UDI

Identifiers

Catalog Number: P40-900-0801 FDA UDI
Primary DI / UDI-DI: 00889795039330 FDA UDI
FDA Product Code: HTZ FDA UDI
GMDN Term: Surgical countersink, 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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical countersink, reusable

HammerTube System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical countersink, reusable.

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Zimmer Cannulated Screw System — Pioneer Surgical Technology, Inc. · Class I
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COUNTERSINK SMALL FRAG — Biomet Orthopedics, Inc. · Class I
Cortical Counter Sink — I.T.S. GmbH · Class I
EVOS — Smith & Nephew, Inc. · Class I
PERLA ® — Spineart · Class II
DART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC. · 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 b24f34f9-49f8-4bff-a2e7-d828b5c823b6 34 fields · synced May 30, 2026