CONDUIT ATP Inserter Hex Driver LET30401T

GUDID 09421028118354

Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.

ENZTEC LIMITED

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 09421028118354
• NIH Device Record Key: 4d276280-f983-4ac8-b375-2fcf7d6b9db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONDUIT ATP Inserter Hex Driver
• Version Model Number: LET30401T
• Catalog Number: LET30401T
• Company DUNS: 592616445
• Company Name: ENZTEC LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	09421028118354 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

[09421028118354]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-12
• Device Publish Date: 2023-12-04

Devices Manufactured by ENZTEC LIMITED

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• 09421038410295 - Enztec Trinket M8x1.25-02: 2024-10-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119252 - Enztec Trinket 3/8-24 UNF-03: 2024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119900 - Enztec Trinket 5/16-24 UNF-01: 2024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119924 - Enztec Trinket M8x1.25-01: 2024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028115056 - Enztec Cup Impactor Alignment Guide - Supine: 2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028115063 - Enztec Cup Impactor Alignment Guide - Lateral: 2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure