PRECICE® Trauma Nail System

FDA UDI

Class I (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name: PRECICE® Trauma Nail System FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: 3.4mm Drill Bit, Short FDA UDI
Model / Reference: DBS1-3.4 FDA UDI
Description: 3.4mm Drill Bit, Short FDA UDI

Identifiers

Catalog Number: DBS1-3.4 FDA UDI
Primary DI / UDI-DI: 00812258028305 FDA UDI
FDA Product Code: HTW 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.4 Millimeter FDA UDI

Category: Cannulated surgical drill bit, single-use

PRECICE® Trauma Nail System by NuVasive Specialized Orthopedics, Inc. — 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: NuVasive Specialized Orthopedics, Inc.

Sources (1)

FDA UDI b2850ce7-72a2-40a0-ab18-c4cc9c1dc601 36 fields · synced May 30, 2026