| Primary Device ID | 06903195107889 |
| NIH Device Record Key | 639b0209-631f-4f5f-a6f6-e8487e59c4a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| Version Model Number | KT-T1L15H2 |
| Catalog Number | CF26010016 |
| 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 | 06903195107889 [Primary] |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[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
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-30 |
| Device Publish Date | 2022-11-22 |