Enztec Cup Impactor Alignment Guide - Supine 4252-2008

GUDID 09421028115056

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: 09421028115056
• NIH Device Record Key: de1bd43e-6e09-4e82-b005-b3faa577947f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enztec Cup Impactor Alignment Guide - Supine
• Version Model Number: 4252-2008
• Catalog Number: 4252-2008
• 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	09421028115056 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

Moist Heat or Steam Sterilization

[09421028115056]

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

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• 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
• 09421028119290 - Kinematic Alignment Caliper – S+N: 2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119306 - Distal Cartilage Shim – 2mm: 2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 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