Cylinder Screw MUAS

GUDID 08806388244027

M1.4

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388244027
• NIH Device Record Key: de8de782-280b-44ab-8f3a-4e95301cbf62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cylinder Screw
• Version Model Number: MUAS
• Catalog Number: MUAS
• 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: true
• 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	08806388244027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203808

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

[08806388244027]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-26
• Device Publish Date: 2021-11-18

On-Brand Devices [Cylinder Screw]

• 08806388244027: M1.4
• 08806388257775: Common M1.4
• 08809977450458: Common