PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26080013

GUDID 06903195109111

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

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable

• Primary Device ID: 06903195109111
• NIH Device Record Key: 94183ce3-b218-4802-b9aa-7cee50a618e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
• Version Model Number: KT-T8L12H2
• Catalog Number: CF26080013
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	06903195109111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214109

FDA Product Code

• GXN: Plate, Cranioplasty, Preformed, Non-Alterable

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06903195109111]

Moist Heat or Steam Sterilization

[06903195109111]

Moist Heat or Steam Sterilization

[06903195109111]

Moist Heat or Steam Sterilization

[06903195109111]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07