iFUSE INTRA X Mallet 501984

GUDID 00857676008553

Eca Medical Instruments

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

• Primary Device ID: 00857676008553
• NIH Device Record Key: e2f8b688-d422-41ef-af03-f4fad06bf104
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFUSE INTRA X Mallet
• Version Model Number: 973-001
• Catalog Number: 501984
• 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	00857676008553 [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

• 00857676008591 - Palm Handle, 2 mm Hex Torque Limiting Instrument: 2024-06-03
• 00857676008607 - Threaded Trimmable Fixation Nail H/W Instrument Pack: 2024-06-03
• 00857676008614 - Threaded Trimmable Fixation Nail F/A Instrument Pack: 2024-06-03
• 00857676008621 - Threaded Trimmable Fixation Nail Sizing Guide Pack: 2024-06-03
• 00857676008553 - iFUSE INTRA X Mallet: 2024-03-26
• 00857676008553 - iFUSE INTRA X Mallet: 2024-03-26
• 00857676008560 - iFUSE INTRA X Assist: 2024-03-26
• 00857676008577 - Orthopedic Cannulated Nail Instrument Pack 3.0 x 50mm: 2024-03-26
• 00857676008584 - Orthopedic Cannulated Nail Instrument Pack 4.0 x 100mm: 2024-03-26