DXTEND HUM BROACH DIA 12 MM 2307-89-012

GUDID 09421038410882

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

ENZTEC LIMITED

Orthopaedic broach

• Primary Device ID: 09421038410882
• NIH Device Record Key: 8af827ef-34f7-49fd-a928-23ee6e406160
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DXTEND HUM BROACH DIA 12 MM
• Version Model Number: 2307-89-012
• Catalog Number: 2307-89-012
• 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	09421038410882 [Primary]

FDA Product Code

• HTR: Rasp

Sterilization

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

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

[09421038410882]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-12
• Device Publish Date: 2025-08-04

Devices Manufactured by ENZTEC LIMITED

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• 09421028111331 - Enztec Classic OCI – Corin Hex Driver: 2026-01-14 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028111362 - Enztec Classic OCI - Tornier Trinket: 2026-01-14 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028115643 - Enztec Classic OCI - Trinket 7 /16-20 UNF-02: 2026-01-14 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410530 - Enztec Trinket M8x1.00-03: 2026-01-13 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038411612 - Offset Acetabular Shell Impactor Hex Driver - Enztec: 2025-12-29 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038411629 - Offset Acetabular Shell Impactor Trinket - Enztec: 2025-12-29 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure