Cylinder Screw AXCS16

GUDID 08809977450458

Common

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809977450458
• NIH Device Record Key: e63756e1-224c-4c71-86d4-fe65ef80bd90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cylinder Screw
• Version Model Number: AXCS16
• Catalog Number: AXCS16
• 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: 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	08809977450458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233450

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809977450458]

Moist Heat or Steam Sterilization

[08809977450458]

Moist Heat or Steam Sterilization

[08809977450458]

Moist Heat or Steam Sterilization

[08809977450458]

Moist Heat or Steam Sterilization

[08809977450458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [Cylinder Screw]

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