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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
Distraction implant preimplantation adjustment device FDA UDI
Device Name
PRECICE Fast Distractor FDA UDI
Model / Reference
PFD1-000 FDA UDI
Description
PRECICE Fast Distractor FDA UDI

Identifiers

Catalog Number
PFD1-000 FDA UDI
Primary DI / UDI-DI
00887517940704 FDA UDI
FDA Product Code
HWN FDA UDI
GMDN Term
Distraction implant preimplantation adjustment device 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Distraction implant preimplantation adjustment device

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

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 f58fc53b-745f-4be8-b01f-857810b4cd16 36 fields · synced May 30, 2026