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

• 09421028112963 - Kinematic Alignment Caliper: 2024-10-21 Intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces
• 09421038410080 - Enztec Trinket 3/8-16 UNC-03: 2024-10-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 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