PROCOTYL® P ENZTEC IMPACTOR HANDLE PPENZHND

GUDID 09421028118972

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

ENZTEC LIMITED

Orthopaedic implant impactor, reusable

• Primary Device ID: 09421028118972
• NIH Device Record Key: c66fdaf4-fb17-4c1a-b2d8-141521dc2c9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROCOTYL® P ENZTEC IMPACTOR HANDLE
• Version Model Number: PPENZHND
• Catalog Number: PPENZHND
• 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	09421028118972 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

[09421028118972]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-16
• Device Publish Date: 2023-11-08

Devices Manufactured by ENZTEC LIMITED

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• 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
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• 09421028119313 - Varus/Valgus Recut Block – 2deg: 2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119382 - Spiked EM/IM 3 Degree Left Tibia Cutting Block: 2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119399 - Spiked EM/IM 3 Degree Right Tibia Cutting Block: 2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure