3.5mm Hex Driver Shaft – AO – 250mm 4200-5354

GUDID 09421028117494

A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Surgical power tool adaptor

• Primary Device ID: 09421028117494
• NIH Device Record Key: 1ac69005-c2e9-454c-98f0-cb078ddf4678
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm Hex Driver Shaft – AO – 250mm
• Version Model Number: 4200-5354
• Catalog Number: 4200-5354
• Company DUNS: 592616445
• Company Name: ENZTEC LIMITED
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421028117494 [Primary]

FDA Product Code

• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

[09421028117494]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-12-05

Devices Manufactured by ENZTEC LIMITED

• 09421028117494 - 3.5mm Hex Driver Shaft – AO – 250mm: 2025-12-15A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421028117494 - 3.5mm Hex Driver Shaft – AO – 250mm: 2025-12-15 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421028117500 - 4.0mm Hex Driver Shaft – AO: 2025-12-15 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421028117517 - 6.0mm Hex Driver Shaft – Zimmer: 2025-12-15 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038410912 - 3.5mm Hex Driver Shaft – AO – 100mm: 2025-12-15 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038410509 - Drill Pin Driver – AO: 2025-11-21 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421028119054 - Neck Holder: 2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119061 - Base: 2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119078 - Head Holder: 2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure