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Signature

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name
Signature FDA UDI
Generic Name
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Device Name
Guide/Bone Model Set FDA UDI
Model / Reference
42-100400 FDA UDI
Description
Guide/Bone Model Set FDA UDI

Identifiers

Catalog Number
42-100400 FDA UDI
Primary DI / UDI-DI
E31442100400 FDA UDI
510(k) Number
K111863 FDA UDI
FDA Product Code
MEH FDA UDI
MAY FDA UDI
LZP FDA UDI
LPH FDA UDI
KWZ FDA UDI
KWY FDA UDI
JDI FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
886.4275 FDA UDI
888.3358 FDA UDI
888.3310 FDA UDI
888.3390 FDA UDI
888.3350 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

No

FDA UDI

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

Cleared under the same submission

K111863 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 6e8f51f0-1299-4e2e-b724-ff272716f644 36 fields · synced May 30, 2026