T8 Driver Accessory Pack

GUDID 00857676008775

Eca Medical Instruments

Cannulated surgical drill bit, single-use

• Primary Device ID: 00857676008775
• NIH Device Record Key: 9c16926a-6216-421b-984b-12c538fcd2df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T8 Driver Accessory Pack
• Version Model Number: 1005
• 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	00857676008775 [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: 2025-06-25
• Device Publish Date: 2025-06-17

Devices Manufactured by Eca Medical Instruments

• 00857676008744 - 2.0MM Drill Accessory Pack: 2025-06-25
• 00857676008751 - 2.7MM Drill Accessory Pack: 2025-06-25
• 00857676008768 - 3.0MM Drill Accessory Pack: 2025-06-25
• 00857676008775 - T8 Driver Accessory Pack: 2025-06-25
• 00857676008775 - T8 Driver Accessory Pack: 2025-06-25
• 00857676008782 - Depth Gauge Accessory Pack: 2025-06-25
• 00857676008799 - Metacarpal Intramedullary Nail Surgery Ready Instrument Kit: 2025-06-25
• 00857676008805 - K-Wire Accessory Pack: 2025-06-25
• 00857676008812 - Fracture Reduction Guide Accessory Pack: 2025-06-25