Cover screw ALCS

GUDID 07290018436059

MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD

Dental implant system

• Primary Device ID: 07290018436059
• NIH Device Record Key: 86fbc856-470c-4df3-8e08-581c4bbc1512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cover screw
• Version Model Number: Alef
• Catalog Number: ALCS
• Company DUNS: 531825934
• Company Name: MEDICAL SYSTEMS AND DEVICES INTERNATIONAL 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: false
• 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	07290018436059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191443

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

[07290018436059]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-01
• Device Publish Date: 2024-01-24

Devices Manufactured by MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD

• 07290019897620 - Ratchet click driver long: 2024-02-07
• 07290019897675 - Implant hand driver short: 2024-02-07
• 07290019897019 - Implant hand driver long: 2024-02-06
• 07290019897026 - Motor mount click driver long: 2024-02-06
• 07290019897071 - Motor mount click driver short: 2024-02-06
• 07290019897125 - Motor mount click driver long: 2024-02-06
• 07290019897156 - Guided ratchet driver long: 2024-02-06
• 07290019897170 - Motor mount click driver short: 2024-02-06