Acutrak 3 MIS Bunion Instrument Kit, 4.0, 3.5, 2.5 (47-0020-S) 1028-001

GUDID 00857676008928

Eca Medical Instruments

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00857676008928
• NIH Device Record Key: a2d1e120-c58d-4ee7-89f8-3ea939615e6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acutrak 3 MIS Bunion Instrument Kit, 4.0, 3.5, 2.5 (47-0020-S)
• Version Model Number: 1028-001
• Catalog Number: 1028-001
• Company DUNS: 084330422
• Company Name: Eca Medical Instruments
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00857676008928 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

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: 2025-11-19
• Device Publish Date: 2025-11-11

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