DynaBuion 280600PKG

GUDID 00810112598094

DynaBunion Full Custom Non-Sterile Case

CROSSROADS EXTREMITY SYSTEMS

Instrument tray, reusable

• Primary Device ID: 00810112598094
• NIH Device Record Key: 3af547d0-12ac-4d45-9223-9f6a8cf77476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaBuion
• Version Model Number: DynaBunion Full Custom Non-Sterile Case
• Catalog Number: 280600PKG
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810112598094 [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

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

Moist Heat or Steam Sterilization

[00810112598094]

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

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• 00810112593037 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Variable Angle Screw Length 8 mm, Blue
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• 00810112593051 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Variable Angle Screw Length 10 mm, Blue