PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26040015

GUDID 06903195108411

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

Cranioplasty plate, non-alterable
Primary Device ID06903195108411
NIH Device Record Key1d4f482e-28e1-445c-83e2-d19437b214dc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Version Model NumberKT-T4L14H2
Catalog NumberCF26040015
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
GS106903195108411 [Primary]

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

Moist Heat or Steam Sterilization


[06903195108411]

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