Enztec Premium Patella Saw Guide – 10mm (1.37mm Blade) 4240-4410

GUDID 09421028118743

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

ENZTEC LIMITED

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09421028118743
• NIH Device Record Key: 04d1d0e2-ce5a-4835-86b3-bea45a489bde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enztec Premium Patella Saw Guide – 10mm (1.37mm Blade)
• Version Model Number: 4240-4410
• Catalog Number: 4240-4410
• 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	09421028118743 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

[09421028118743]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-01
• Device Publish Date: 2023-10-24

Devices Manufactured by ENZTEC LIMITED

• 09421028119320 - Intramedullary Alignment Jig: 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119337 - Intramedullary Rod Lock Knob: 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119344 - Spiked EM Alignment Jig: 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119351 - Spiked EM Slope Guide: 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119368 - Spiked EM/IM Alignment Rod: 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119375 - Lock Knob: 2024-12-25 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410288 - Enztec Patella Shim - 4mm: 2024-12-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118651 - Adjustable Cutting Block – 1.35mm: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure