CastleLoc Pectus Bar System Instrument Set

GUDID 08809986466341

Connector Holder (Buttress Thread)

L&K BIOMED CO. ,LTD.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 08809986466341
• NIH Device Record Key: f32c98ab-d018-49de-99ae-68964b6f06c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CastleLoc Pectus Bar System Instrument Set
• Version Model Number: PB01-0056
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: false
• 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	08809986466341 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

[08809986466341]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-09
• Device Publish Date: 2025-04-01

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
• 08809986460240: Bar template 15inch
• 08809986460233: Bar template 14.5inch
• 08809986460226: Bar template 14inch
• 08809986460219: Bar template 13.5inch
• 08809986460202: Bar template 13inch
• 08809986460196: Bar template 12.5inch
• 08809986460189: Bar template 12inch
• 08809986460172: Bar template 11.5inch
• 08809986460165: Bar template 11inch
• 08809986460158: Bar template 10.5inch
• 08809986460141: Bar template 10inch
• 08809986460134: Bar template 9.5inch
• 08809986460127: Bar template 9inch
• 08809986466334: Connector Holder (Unified Thread)
• 08809986466426: Crane System Container Bottom Tray
• 08809986466419: Crane System Container Upper Tray
• 08809986466402: Crane System Container
• 08809986466396: Crane System Container Cover
• 08809986466389: Introducer Bar 400mm
• 08809986466372: Introducer Bar 300mm
• 08809986466365: End-Hole Lever Bender Curved
• 08809986466358: End-Hole Lever Bender Straight
• 08809986466341: Connector Holder (Buttress Thread)
• 08809986466327: In-Situ Bending Iron Curved B
• 08809986466310: In-Situ Bending Iron Curved A
• 08809986466303: In-Situ Bending Iron Straight
• 08809986466297: CastleLoc Crane System
• 08809986479549: Bar Distance Gauge
• 08809986479532: End-Hole Lever Bender Curved(Circle 2H)
• 08809986479525: End-Hole Lever Bender Straight(Circle 2H)
• 08809986479518: End-Hole Lever Bender Curved(Circle 1H)
• 08809986479501: End-Hole Lever Bender Straight(Circle 1H)
• 08809986479495: Bar Removal Gripper
• 08809986479488: Nut Final Tightening Driver Shaft