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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
CT SIG TKA GDE/MDL SET 04-07 FDA UDI
Model / Reference
42-422567 FDA UDI
Description
CT SIG TKA GDE/MDL SET 04-07 FDA UDI

Identifiers

Catalog Number
42-422567 FDA UDI
Primary DI / UDI-DI
E31442422567 FDA UDI
510(k) Number
K102795 FDA UDI
FDA Product Code
JWH FDA UDI
MBH FDA UDI
OOG FDA UDI
OIY FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3565 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

K102795 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 83d1f950-35fb-4f88-b5d9-b76170c6157d 36 fields · synced May 31, 2026