MiniBunion 280020PKG

GUDID 00810112597851

MiniBunion Instruments Tray

CROSSROADS EXTREMITY SYSTEMS

Instrument tray, reusable

• Primary Device ID: 00810112597851
• NIH Device Record Key: 32de6a0e-2d4b-4873-b9a7-a7ae539279c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniBunion
• Version Model Number: MiniBunion Instruments Tray
• Catalog Number: 280020PKG
• Company DUNS: 058864308
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• Device Count: 1
• DM Exempt: false
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810112597851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202268

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

[00810112597851]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-15
• Device Publish Date: 2024-08-07

On-Brand Devices [MiniBunion]

• 00815432029228: The MiniBunion Plating System is intended for fixation of osteotomies and corrective procedures
• 00810112597875: MiniBunion Saw Guide
• 00810112597868: MIS Bunion Plate Inserter
• 00810112597851: MiniBunion Instruments Tray
• 00810112597844: MiniBunion Non-Locking Drill Guide