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PRECICE System

FDA UDI

Class I (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name
PRECICE System FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Trocar Sleeve Hto Semi-Extended FDA UDI
Model / Reference
SET1-001 FDA UDI
Description
Trocar Sleeve Hto Semi-Extended FDA UDI

Identifiers

Primary DI / UDI-DI
00812258028473 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

PRECICE System by NuVasive Specialized Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NuVasive Specialized Orthopedics, Inc.

Sources (1)

  • FDA UDI f0145624-9404-4090-a039-693b515f726b 34 fields · synced Jun 8, 2026