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Visionaire Uni

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name
VISIONAIRE UNI FDA UDI
Generic Name
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Device Name
NONSTERILE VISIONAIRE UNI CUTTING GUIDE FDA UDI
Model / Reference
V0500001 FDA UDI
Description
NONSTERILE VISIONAIRE UNI CUTTING GUIDE FDA UDI

Identifiers

Catalog Number
V0500001 FDA UDI
Primary DI / UDI-DI
00885556700167 FDA UDI
510(k) Number
K172650 FDA UDI
K173970 FDA UDI
K202207 FDA UDI
FDA Product Code
HSX FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3520 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Visionaire Uni by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K172650 also covers:

K173970 also covers:

K202207 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Materialise NV

Sources (1)

  • FDA UDI ca647895-ae09-42a9-854d-f9c82bf56c05 36 fields · synced Jun 6, 2026