PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010016

GUDID 06903195107889

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

Cranioplasty plate, non-alterable
Primary Device ID06903195107889
NIH Device Record Key639b0209-631f-4f5f-a6f6-e8487e59c4a1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Version Model NumberKT-T1L15H2
Catalog NumberCF26010016
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
GS106903195107889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


[06903195107889]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-30
Device Publish Date2022-11-22