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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
Orthopaedic implant impactor, reusable FDA UDI
Device Name
Orthopedic surgical instrument - for use with the intramedullary limb lengthening system FDA UDI
Model / Reference
IMA1-000 FDA UDI
Description
Orthopedic surgical instrument - for use with the intramedullary limb lengthening system FDA UDI

Identifiers

Catalog Number
IMA1-000 FDA UDI
Primary DI / UDI-DI
00812258022099 FDA UDI
FDA Product Code
HWA FDA UDI
GMDN Term
Orthopaedic implant impactor, 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 implant impactor, reusable

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

Similar devices

Also classified as Orthopaedic implant impactor, 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 64c03c84-bcf2-4d24-a554-8877e7312b9f 36 fields · synced Jun 8, 2026