PROCOTYL® P ENZTEC LATERAL ALIGNMENT GUIDE PPENZLAG

GUDID 09421028118934

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: 09421028118934
• NIH Device Record Key: 2f9702bb-5a8b-4273-98ac-ed10cabd8b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROCOTYL® P ENZTEC LATERAL ALIGNMENT GUIDE
• Version Model Number: PPENZLAG
• Catalog Number: PPENZLAG
• 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	09421028118934 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

[09421028118934]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-23
• Device Publish Date: 2024-08-15

Devices Manufactured by ENZTEC LIMITED

• 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
• 09421028118668 - 3.5mm Ball Hex Driver – 340mm: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118705 - MODULAR BROACH HANDLE, DUAL OFFSET, RIGHT: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118712 - MODULAR BROACH HANDLE, DUAL OFFSET, LEFT: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119030 - Adjustable Cutting Block – 1.27mm: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119085 - MODULAR BROACH HANDLE, GRIP: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119092 - MODULAR BROACH HANDLE, STRIKE PLATE: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure