N2 MC92-0002A

GUDID 08809822769971

Megagen Implant Co. Ltd

Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system

• Primary Device ID: 08809822769971
• NIH Device Record Key: 7d875c41-34fd-4238-b153-f1f4cc9ebe57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N2
• Version Model Number: N2 (Mount A Type)
• Catalog Number: MC92-0002A
• Company DUNS: 687388178
• Company Name: Megagen Implant 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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	08809822769971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211556

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

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

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

[08809822769971]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-30
• Device Publish Date: 2023-11-22

On-Brand Devices [N2]

• 08809822769971: N2 (Mount A Type)
• 08809822769964: N2 (Cart A Type)
• 08809822769957: N2 (Mount B Type)
• 08809822769940: N2 (Cart B Type)
• 08809977452049: N2 (Continental Type)