Kelyniam CCI PEEK-IM2001

GUDID 00817580023998

PEEK Customized Craniofacial Implant, Small CCI040218-AE1

KELYNIAM GLOBAL, INC.

Cranioplasty plate, non-alterable

• Primary Device ID: 00817580023998
• NIH Device Record Key: d1c2d35e-fa23-43fb-8ad2-1b77ebe2796f
• Commercial Distribution Discontinuation: 2019-08-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Kelyniam CCI
• Version Model Number: PEEK-IM2001
• Catalog Number: PEEK-IM2001
• Company DUNS: 785088829
• Company Name: KELYNIAM GLOBAL, INC.
• 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: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817580023998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103582

FDA Product Code

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

Sterilization

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

[00817580023998]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-16
• Device Publish Date: 2019-08-08

Devices Manufactured by KELYNIAM GLOBAL, INC.

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• 00810125924576 - KELYNIAM CSI: 2024-04-24 PEEK Customized Cranial Implant, XLARGE CSI040924-BJ1
• 00810125924583 - KELYNIAM CSI: 2024-04-24 PEEK Customized Cranial Implant, XLARGE CSI041024-DB1
• 00810125924590 - KELYNIAM CSI: 2024-04-24 PEEK Customized Cranial Implant, SMALL CSI041024-JB1
• 00810125924606 - KELYNIAM CSI: 2024-04-24 PEEK Customized Cranial Implant, XLARGE CSI041624-AS1
• 00810125924521 - KELYNIAM CSI: 2024-04-17 PEEK Customized Craniofacial Implant, XLARGE CCI040424-GW1
• 00810125924538 - KELYNIAM CSI: 2024-04-17 PEEK Customized Cranial Implant, XLARGE CSI040824-JC1
• 00810125924545 - KELYNIAM CSI: 2024-04-17 PEEK Customized Cranial Implant, XLARGE CSI040824-DG1