Orthopedic Cannulated Nail Instrument Pack 4.0 x 100mm THN00262

GUDID 00857676008584

Eca Medical Instruments

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• Primary Device ID: 00857676008584
• NIH Device Record Key: 7c68a421-cfb4-4349-bd65-69d78255371e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthopedic Cannulated Nail Instrument Pack 4.0 x 100mm
• Version Model Number: 964-002
• Catalog Number: THN00262
• 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	00857676008584 [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
• 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
• 00857676008584 - Orthopedic Cannulated Nail Instrument Pack 4.0 x 100mm: 2024-03-26