KELYNIAM CSI PEEK-IM1004

GUDID 00810125927256

PEEK Customized Cranial Implant, X-LARGE CSI060625-RS1

KELYNIAM GLOBAL, INC.

Cranioplasty plate, non-alterable

• Primary Device ID: 00810125927256
• NIH Device Record Key: 05bd27da-2b9b-46f5-8483-785ca7c99196
• Commercial Distribution Discontinuation: 2025-06-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KELYNIAM CSI
• Version Model Number: PEEK-IM1004
• Catalog Number: PEEK-IM1004
• 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	00810125927256 [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

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

[00810125927256]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-18
• Device Publish Date: 2025-06-10

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