Patella Drill Guide – Restor3d Round 38-44 4240-4246

GUDID 09421038410646

A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09421038410646
• NIH Device Record Key: 32c248ee-47ee-4d37-a726-53f921fcf4be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patella Drill Guide – Restor3d Round 38-44
• Version Model Number: 4240-4246
• Catalog Number: 4240-4246
• 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	09421038410646 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

[09421038410646]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23

Devices Manufactured by ENZTEC LIMITED

• 09421038410875 - DXTEND HUM BROACH DIA 10 MM: 2025-08-12 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410882 - DXTEND HUM BROACH DIA 12 MM: 2025-08-12 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410899 - DXTEND HUM BROACH DIA 14 MM: 2025-08-12 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410905 - DXTEND HUM BROACH DIA 16 MM: 2025-08-12 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119795 - Patella Drill Guide – Corentec 26: 2025-08-07 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119962 - Patella Drill Guide – Corentec 28: 2025-08-07 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119979 - Patella Drill Guide – Corentec 30: 2025-08-07 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119986 - Patella Drill Guide – Corentec 32: 2025-08-07 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure