Enztec XR Trinket 5/16-24 UNF-02 4252-2448

GUDID 09421038410608

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

ENZTEC LIMITED

Orthopaedic implant impactor, reusable

• Primary Device ID: 09421038410608
• NIH Device Record Key: 0b148e16-2a66-497f-9954-bf06bfb02f6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enztec XR Trinket 5/16-24 UNF-02
• Version Model Number: 4252-2448
• Catalog Number: 4252-2448
• Company DUNS: 592616445
• Company Name: ENZTEC LIMITED
• Device Count: 1
• DM Exempt: true
• 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	09421038410608 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

[09421038410608]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-21
• Device Publish Date: 2025-04-11

Devices Manufactured by ENZTEC LIMITED

• 09421038410554 - 3.5mm Ball Hex Driver – 225mm: 2025-04-21 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410608 - Enztec XR Trinket 5/16-24 UNF-02: 2025-04-21A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410608 - Enztec XR Trinket 5/16-24 UNF-02: 2025-04-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410776 - Enztec XR Trinket 3/8-24 UNF-04: 2025-04-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119047 - Enztec Dual Mobility Head Press: 2025-03-05 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410462 - Table Adaptor: 2025-03-05 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119269 - LEGION Kinematic Alignment Distal Valgus Guide: 2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119276 - JOURNEY Kinematic Alignment Distal Valgus Guide - Left: 2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119283 - JOURNEY Kinematic Alignment Distal Valgus Guide - Right: 2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure