CastleLoc Pectus Bar System Instrument Set PB05-1005

GUDID 08809986460424

Basic Instrument Case - Screw Caddy

L&K BIOMED CO. ,LTD.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 08809986460424
• NIH Device Record Key: 6d7a652f-eed3-4287-ac94-3ff98d23d3e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CastleLoc Pectus Bar System Instrument Set
• Version Model Number: PB05-1005
• Catalog Number: PB05-1005
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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	08809986460424 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08809986460424]

Moist Heat or Steam Sterilization

[08809986460424]

Moist Heat or Steam Sterilization

[08809986460424]

Moist Heat or Steam Sterilization

[08809986460424]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-19
• Device Publish Date: 2024-12-11

On-Brand Devices [CastleLoc Pectus Bar System Instrument Set]

• 08809986460509: Implant Case - Caddy (removal)
• 08809986460493: Implant Case - Caddy
• 08809986460479: Implant Case - Tray3
• 08809986460462: Implant Case - Tray2
• 08809986460455: Implant Case - Tray1
• 08809986460448: Implant Case - Container
• 08809986460431: Implant Case - Cover
• 08809986460424: Basic Instrument Case - Screw Caddy
• 08809986460417: Basic Instrument Case - Lower tray
• 08809986460387: Basic Instrument Case - Cover
• 08809986460288: Bar template 17inch
• 08809986460271: Bar template 16.5inch
• 08809986460264: Bar template 16inch
• 08809986460257: Bar template 15.5inch
• 08806344399679: Sternum Elevation Screw 8
• 08806344399662: Sternum Elevation Screw 8