ZENEX Direct Kit

GUDID 08800070237083

Izenimplant Co., Ltd.

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

• Primary Device ID: 08800070237083
• NIH Device Record Key: 5fdacfef-ab97-4353-ab13-41fbb33a3836
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENEX Direct Kit
• Version Model Number: ZENDTTKIT
• Company DUNS: 694625347
• Company Name: Izenimplant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• 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	08800070237083 [Primary]

Sterilization

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

[08800070237083]

Moist Heat or Steam Sterilization

[08800070237083]

Moist Heat or Steam Sterilization

[08800070237083]

Moist Heat or Steam Sterilization

[08800070237083]

Moist Heat or Steam Sterilization

[08800070237083]

Moist Heat or Steam Sterilization

[08800070237083]

Moist Heat or Steam Sterilization

[08800070237083]

Moist Heat or Steam Sterilization

[08800070237083]

Moist Heat or Steam Sterilization

[08800070237083]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-03
• Device Publish Date: 2025-06-25

On-Brand Devices [ZENEX Direct Kit]

• 08800070237090: ZENDTRKIT
• 08800070237083: ZENDTTKIT
• 08800070237076: ZENDTSKIT