Ball attachment kit BAKIT2

GUDID 07290018434963

MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD

Dental implant system

• Primary Device ID: 07290018434963
• NIH Device Record Key: 093c71ea-5f51-4e0f-a620-3965a730fcc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ball attachment kit
• Version Model Number: 2mm
• Catalog Number: BAKIT2
• 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: true
• 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	07290018434963 [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

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

Moist Heat or Steam Sterilization

[07290018434963]

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

On-Brand Devices [Ball attachment kit]

• 07290018436912: 7mm
• 07290018435007: 6mm
• 07290018434994: 5mm
• 07290018434987: 4mm
• 07290018434970: 3mm
• 07290018434963: 2mm