PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26040007

GUDID 06903195108336

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

Cranioplasty plate, non-alterable
Primary Device ID06903195108336
NIH Device Record Key87976878-9cc5-46f1-abec-e613fd241c08
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Version Model NumberKT-T4L7H1
Catalog NumberCF26040007
Company DUNS529652129
Company NameKontour(Xi'An) Medical Technology Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106903195108336 [Primary]

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


[06903195108336]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-06-09
Device Publish Date2022-12-08