Arthrex AR-8924VIN-DS

GUDID 00857676008171

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

• Primary Device ID: 00857676008171
• NIH Device Record Key: e33858bd-77d1-44c8-93c2-68dfad5d4bb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex
• Version Model Number: 2.4 mm Volar Distal Radius Instrument System
• Catalog Number: AR-8924VIN-DS
• 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	00857676008171 [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: 2023-04-05
• Device Publish Date: 2023-03-28

On-Brand Devices [Arthrex ]

• 00857676008195: 2.4 mm Volar Distal Radius Removal Driver
• 00857676008188: 2.4 mm Volar Distal Radius Plate Template
• 00857676008171: 2.4 mm Volar Distal Radius Instrument System