PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010008

GUDID 06903195107803

Kontour(Xi'An) Medical Technology Co.,Ltd.

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable

Primary Device ID	06903195107803
NIH Device Record Key	e65db03f-8fa5-498d-ba7e-b2769d2b6a5f
Commercial Distribution Status	In Commercial Distribution
Brand Name	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Version Model Number	KT-T1L18H1
Catalog Number	CF26010008
Company DUNS	529652129
Company Name	Kontour(Xi'An) Medical Technology Co.,Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06903195107803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K214109

FDA Product Code

GXN	Plate, Cranioplasty, Preformed, Non-Alterable