CastleLoc Pectus Bar System

GUDID 08809986466242

CastleLoc Pectus Bar – Curved 1

L&K BIOMED CO. ,LTD.

Funnel chest remodelling bar

• Primary Device ID: 08809986466242
• NIH Device Record Key: ef738268-2c70-44cc-b6d7-57f69624f88d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CastleLoc Pectus Bar System
• Version Model Number: PB28-1105
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	08809986466242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243357

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

[08809986466242]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-21
• Device Publish Date: 2025-03-13

On-Brand Devices [CastleLoc Pectus Bar System]

• 08809986461728: Stabilizer – Connector Nut
• 08809986461711: CastleLoc Pectus Bar – Curved 1
• 08809986461704: CastleLoc Pectus Bar – Curved 1
• 08809986461698: CastleLoc Pectus Bar – Curved 1
• 08809986461681: CastleLoc Pectus Bar – Curved 1
• 08809986461186: Stabilizer – Connector
• 08809986461179: CastleLoc Pectus Bar Curved 3 (with twisted both tip - CounterClockwise)
• 08809986461162: CastleLoc Pectus Bar Curved 3 (with twisted both tip - CounterClockwise)
• 08809986461155: CastleLoc Pectus Bar – Curved 2 (with twisted both tip-Clockwise)
• 08809986461148: CastleLoc Pectus Bar – Curved 2 (with twisted both tip-Clockwise)
• 08809986461131: CastleLoc Pectus Bar – Curved 1
• 08809986461124: CastleLoc Pectus Bar – Curved 1
• 08809986466280: CastleLoc Pectus Bar – Curved 1
• 08809986466273: CastleLoc Pectus Bar – Curved 1
• 08809986466266: CastleLoc Pectus Bar – Curved 1
• 08809986466259: CastleLoc Pectus Bar – Curved 1
• 08809986466242: CastleLoc Pectus Bar – Curved 1
• 08809986466235: Stabilizer – Bridge 2 (type2)
• 08809986466228: Stabilizer – Bridge 2 (type2)
• 08809986466211: Stabilizer – Bridge 2 (type2)
• 08809986466204: Stabilizer – Bridge 2 (type2)
• 08809986466198: Stabilizer – Bridge 2 (type2)
• 08809986466181: Stabilizer – Bridge 2 (type2)
• 08809986466174: Stabilizer – Bridge 2 (type2)
• 08809986466167: Stabilizer – Bridge 2 (type2)
• 08809986466150: Stabilizer – Bridge 2 (type2)