3D Anatomic Model

FDA UDI

Class II (US FDA UDI)

by Ricoh USA, Inc.

Identity

Trade Name: 3D Anatomic Model FDA UDI
Generic Name: Custom-made organ/bone anatomy model FDA UDI
Device Name: 3D printed patient specific replicas of patient anatomy FDA UDI
Model / Reference: 1 FDA UDI
Description: 3D printed patient specific replicas of patient anatomy FDA UDI

Identifiers

Primary DI / UDI-DI: G003DM01 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: Custom-made organ/bone anatomy model FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Custom-made organ/bone anatomy model

3D Anatomic Model by Ricoh USA, 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
Cadence Chamfer Cut Total Ankle System — 3D SYSTEMS, INC. · Class II
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
Vantage 3D PSI — 3D SYSTEMS, INC. · Class II

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: Ricoh USA, Inc.

Sources (1)

FDA UDI 007ffd87-3aa5-430a-b846-10fb64c86472 33 fields · synced May 30, 2026