TruFIX 806-003

GUDID 00857676008201

Eca Medical Instruments

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

• Primary Device ID: 00857676008201
• NIH Device Record Key: 1fd78a28-42b7-4eb7-a190-6bd63855b31c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruFIX
• Version Model Number: Fixed Driver AO, Small Axial
• Catalog Number: 806-003
• 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	00857676008201 [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: 2024-07-25
• Device Publish Date: 2024-07-17

On-Brand Devices [TruFIX]

• 00857676008218: Fixed Driver AO, Small Axial
• 00857676008201: Fixed Driver AO, Small Axial