PRECICE® Approach Instrument Tray

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name: PRECICE® Approach Instrument Tray FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: Surgical instrument tray containing orthopedic surgical instruments FDA UDI
Model / Reference: NGI2-000 FDA UDI
Description: Surgical instrument tray containing orthopedic surgical instruments FDA UDI

Identifiers

Catalog Number: NGI2-000 FDA UDI
Primary DI / UDI-DI: 00812258029210 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 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

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: Instrument tray, reusable

PRECICE® Approach Instrument Tray by NuVasive Specialized Orthopedics, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: NuVasive Specialized Orthopedics, Inc.

Sources (1)

FDA UDI d0628e27-71cd-4514-b182-cd42a5cfead1 36 fields · synced Jun 8, 2026