Vantage 3D PSI

FDA UDI

Class II (US FDA UDI)

by 3d Systems, Inc.

Identity

Trade Name: Vantage 3D PSI FDA UDI
Generic Name: Custom-made organ/bone anatomy model FDA UDI
Device Name: A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. FDA UDI
Model / Reference: Anatomical Model FDA UDI
Description: A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. FDA UDI

Identifiers

Primary DI / UDI-DI: 00816847022811 FDA UDI
FDA Product Code: OYK FDA UDI
GMDN Term: Custom-made organ/bone anatomy model FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 25 Millimeter FDA UDI

Category: Custom-made organ/bone anatomy model

Vantage 3D PSI by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made organ/bone anatomy model.

IPS — KLS-Martin L.P. · Class I
IPS — KLS-Martin L.P. · Class I
Match Point System — Materialise NV · Class II
ProPlan CMF — Materialise NV · Class I
ProPlan CMF — Materialise NV · Class I
ProPlan CMF — Materialise NV · Class I
Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, LLC · Class III
IPS — KLS-Martin L.P. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: 3d Systems, Inc.

Sources (1)

FDA UDI 206b154d-dbf7-4a53-b5e4-dc2db17cb33c 34 fields · synced May 30, 2026