iFUSE INTRA X Assist 501986

GUDID 00857676008560

Eca Medical Instruments

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

• Primary Device ID: 00857676008560
• NIH Device Record Key: 90a4f4d3-882c-4a70-aeef-7551eb6bd903
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFUSE INTRA X Assist
• Version Model Number: 973-002
• Catalog Number: 501986
• 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	00857676008560 [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: 2024-03-26
• Device Publish Date: 2024-03-18

Devices Manufactured by Eca Medical Instruments

• 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
• 00850078396037 - MIS Bunion - 1.6mm Guide Wire (x2) (47-0031-S): 2025-11-19
• 00850078396044 - MIS Bunion - 2.0mm Guide Wire (x2) (47-0032-S): 2025-11-19
• 00857676008881 - Arsenal Foot™ Joint Prep Kit (330-00-100): 2025-11-19
• 00857676008928 - Acutrak 3 MIS Bunion Instrument Kit, 4.0, 3.5, 2.5 (47-0020-S): 2025-11-19