AnyOne External Fixture EF5008C

GUDID 08806388213511

AnyOne External Implant System

Megagen Implant Co. Ltd

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• Primary Device ID: 08806388213511
• NIH Device Record Key: ef8877d7-f460-4e0f-b5cf-1d69980485cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyOne External Fixture
• Version Model Number: EF5008
• Catalog Number: EF5008C
• 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	08806388213511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203554

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

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