Constrictor® Mini for Syndesmosis Repair AB-3000

GUDID 00854629006734

Dunamis Mini Adjustable Fixation Button System

DUNAMIS MEDICAL, LLC

Orthopaedic fixation suture button

• Primary Device ID: 00854629006734
• NIH Device Record Key: 6a5b1c84-8d65-4bc1-a8f1-dcfde1ec913c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Constrictor® Mini for Syndesmosis Repair
• Version Model Number: AB-3000
• Catalog Number: AB-3000
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00854629006734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191319

FDA Product Code

• HTN: Washer, Bolt Nut

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-20
• Device Publish Date: 2021-05-12

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• 00854629006789 - Constrictor® Mini Syndesmosis Repair Kit: 2024-09-27 Constrictor® Mini Syndesmosis Repair Kit
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