CONDUIT ATP Cobb 18mm 36° Left 287361361

GUDID 09421028118422

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: 09421028118422
• NIH Device Record Key: 1692eb62-8934-46a6-9061-e28d62b0e059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONDUIT ATP Cobb 18mm 36° Left
• Version Model Number: 287361361
• Catalog Number: 287361361
• 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	09421028118422 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

Moist Heat or Steam Sterilization

[09421028118422]

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