SD420505

GUDID H980SD42050503

PSI SD420.505 TITANIUM IMPLANT

Synthes GmbH

Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis

Primary Device ID	H980SD42050503
NIH Device Record Key	3d10024c-111b-48c4-a99b-0b7f1edac897
Commercial Distribution Status	In Commercial Distribution
Version Model Number	SD420.505
Catalog Number	SD420505
Company DUNS	486711679
Company Name	Synthes GmbH
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587074887 [Primary]
HIBCC	H980SD42050503 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K033868

FDA Product Code

GXN	PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE