| Primary Device ID | 06903195107995 |
| NIH Device Record Key | 57c8ce21-dcfc-49b9-9224-52b488f570bc |
| Commercial Distribution Discontinuation | 2025-04-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| Version Model Number | KT-T2L8H2 |
| Catalog Number | CF26020009 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 06903195107995 [Primary] |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
[06903195107995]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-05-07 |
| Device Publish Date | 2022-12-08 |