MIS Bunion - 1.6mm Guide Wire (x2) (47-0031-S) 1032-004

GUDID 00850078396037

Eca Medical Instruments

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

• Primary Device ID: 00850078396037
• NIH Device Record Key: 7a0089fe-4bec-4fb7-b634-3453d82673e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS Bunion - 1.6mm Guide Wire (x2) (47-0031-S)
• Version Model Number: 1032-004
• Catalog Number: 1032-004
• 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	00850078396037 [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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• 00850078396112 - TransLoc 3D, 18” Wire and Measurement Guide: 2025-11-25
• 00850078396006 - MIS Bunion - Elevator (47-0030-S): 2025-11-19
• 00850078396013 - MIS Bunion Accessory Kit (47-0028-S): 2025-11-19
• 00850078396020 - MIS Bunion - 2.2 x 20mm Burr (47-0029-S): 2025-11-19