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

• 00857676008638 - Threaded Trimmable Fixation Nail Instrument Pack 5.5: 2024-10-29
• 00857676008201 - TruFIX: 2024-07-25
• 00857676008218 - TruFIX: 2024-07-25
• 00857676008300 - TruTorq: 2024-07-25
• 00857676008515 - TruTorq: 2024-07-25
• 00857676008522 - TruTorq: 2024-07-25
• 00857676008539 - TruTorq: 2024-07-25
• 00857676008591 - Palm Handle, 2 mm Hex Torque Limiting Instrument: 2024-06-03