PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26030016

GUDID 06903195108244

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

Cranioplasty plate, non-alterable
Primary Device ID06903195108244
NIH Device Record Key8df9b09a-3955-49ce-8fbc-3515e65d58e4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Version Model NumberKT-T3L15H2
Catalog NumberCF26030016
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
GS106903195108244 [Primary]

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

Moist Heat or Steam Sterilization


[06903195108244]

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