PRECICE® Intramedullary Limb Lengthening System Instrument

FDA UDI

Class I (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name: PRECICE® Intramedullary Limb Lengthening System Instrument FDA UDI
Generic Name: Surgical mallet FDA UDI
Device Name: Orthopedic surgical instrument (mallet) - for use with the intramedullary limb lengthening system FDA UDI
Model / Reference: RMA1-000 FDA UDI
Description: Orthopedic surgical instrument (mallet) - for use with the intramedullary limb lengthening system FDA UDI

Identifiers

Catalog Number: RMA1-000 FDA UDI
Primary DI / UDI-DI: 00812258021917 FDA UDI
FDA Product Code: HXL FDA UDI
GMDN Term: Surgical mallet 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical mallet

PRECICE® Intramedullary Limb Lengthening System Instrument by NuVasive Specialized Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID

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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 b77b28d1-6e99-400e-af7e-bed12babab79 36 fields · synced May 30, 2026