ExFeel Internal Fixture ISDB4113E

GUDID 08806388222728

ExFeel Internal

Megagen Implant Co. Ltd

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• Primary Device ID: 08806388222728
• NIH Device Record Key: f7f0062a-8a95-4475-bb10-677532b84f3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExFeel Internal Fixture
• Version Model Number: ISDB4113E
• Catalog Number: ISDB4113E
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08806388222728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052369

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [ExFeel Internal Fixture]

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• 08809728991568: ExFeel Internal
• 08809728991551: ExFeel Internal
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• 08809728991513: ExFeel Internal
• 08809728991506: ExFeel Internal
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• 08809728991483: ExFeel Internal
• 08809728991476: EX
• 08809728991469: EX
• 08806388222957: ExFeel Internal
• 08806388222940: ExFeel Internal
• 08806388222889: ExFeel Internal
• 08806388222841: ExFeel Internal
• 08806388222803: ExFeel Internal
• 08806388222766: ExFeel Internal
• 08806388222728: ExFeel Internal
• 08806388222681: ExFeel Internal
• 08806388222643: ExFeel Internal
• 08806388222605: ExFeel Internal
• 08806388222575: ExFeel Internal
• 08806388222568: ExFeel Internal