RI.KNEE Adjustable Tibia Tray Insert 4000-6070

GUDID 09421028118248

Tray/case used to hold other medical devices

ENZTEC LIMITED

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 09421028118248
• NIH Device Record Key: 88894d20-a9f2-4145-8f40-4adc8e430a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RI.KNEE Adjustable Tibia Tray Insert
• Version Model Number: 4000-6070
• Catalog Number: 4000-6070
• 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	09421028118248 [Primary]

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

[09421028118248]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-26
• Device Publish Date: 2023-07-18

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• 09421028118941 - PROCOTYL® P ENZTEC STRAIGHT HANDLE: 2024-03-08 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
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• 09421028119009 - Double Offset Broach Handle M2 Connection - Right: 2024-02-16 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119016 - Double Offset Broach Handle M2 Connection - Left: 2024-02-16 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure