ZENEX Guide Mini Kit

GUDID 08800070231708

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08800070231708
• NIH Device Record Key: e3470342-1b99-4d6c-accc-1889b8c8976b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENEX Guide Mini Kit
• Version Model Number: ZENGMKIT
• Company DUNS: 694625347
• Company Name: Izenimplant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800070231708 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

[08800070231708]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [ZENEX Guide Mini Kit]

• 08800070231777: R-System
• 08800070231760: T-System
• 08800070231753: I-System
• 08800070231708: ZENGMKIT
• 08800070233306: T-System All-in-One