← Back to catalogue

Trumatch

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name
TRUMATCH FDA UDI
Generic Name
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Device Name
Midface Reconstruction kit FDA UDI
Model / Reference
SD980.032 FDA UDI
Description
Midface Reconstruction kit FDA UDI

Identifiers

Catalog Number
SD980.032 FDA UDI
Primary DI / UDI-DI
05420060380761 FDA UDI
510(k) Number
K243637 FDA UDI
FDA Product Code
DZJ FDA UDI
LLZ FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4120 FDA UDI
892.2050 FDA UDI
Commercial Distribution
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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made organ/bone anatomy model/surgical guide kit

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

Similar devices

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

Cleared under the same submission

K243637 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Materialise NV

Sources (1)

  • FDA UDI f7d22f40-13b1-401c-b01c-0561c830f1ff 35 fields · synced Jun 8, 2026