Materialise Personalized Solutions O-01-0-200000-0111-010

GUDID 05420060343056

Hand Osteotomy Model

Materialise NV

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

Primary Device ID	05420060343056
NIH Device Record Key	23ae21f1-eba9-401e-9a9a-8e1df4a82580
Commercial Distribution Status	In Commercial Distribution
Brand Name	Materialise Personalized Solutions
Version Model Number	O-01-0-200000-0111-010
Catalog Number	O-01-0-200000-0111-010
Company DUNS	373139427
Company Name	Materialise NV
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420060343056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112389

FDA Product Code

PBF	Orthopaedic Surgical Planning And Instrument Guides