ZENEX Guide Flattening Drill

GUDID 08800070231647

Izenimplant Co., Ltd.

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

• Primary Device ID: 08800070231647
• NIH Device Record Key: 1df21b0f-7079-4485-8e72-851a0bf95f97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENEX Guide Flattening Drill
• Version Model Number: ZGFD4610R
• Company DUNS: 694625347
• Company Name: Izenimplant Co., Ltd.
• 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: 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	08800070231647 [Primary]

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

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

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

[08800070231647]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-15
• Device Publish Date: 2023-03-07

On-Brand Devices [ZENEX Guide Flattening Drill]

• 08800070231661: ZGFD5209W
• 08800070231654: ZGFD4612R
• 08800070231647: ZGFD4610R
• 08800070231630: ZGFD4609R
• 08800070231623: ZGFD3712M
• 08800070234778: ZGFD6309W
• 08800070234761: ZGFD4712R
• 08800070234754: ZGFD4710R
• 08800070234747: ZGFD4709R
• 08800070230596: ZGFD3512M