PRECICE® Instruments

FDA UDI

Class I (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name: PRECICE® Instruments FDA UDI
Generic Name: Orthopaedic implant driver FDA UDI
Device Name: Orthopedic surgical instrument - Screw driver, 3.5 mm, long cannulated FDA UDI
Model / Reference: SDL2-000 FDA UDI
Description: Orthopedic surgical instrument - Screw driver, 3.5 mm, long cannulated FDA UDI

Identifiers

Catalog Number: SDL2-000 FDA UDI
Primary DI / UDI-DI: 00812258029135 FDA UDI
FDA Product Code: HXX FDA UDI
GMDN Term: Orthopaedic implant driver 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic implant driver

PRECICE® Instruments 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 d7e73fe2-6f2a-4c84-ae05-45e4fa6b4987 36 fields · synced Jun 8, 2026