‘MagnaCap’ Magnetic Retention System VF-LAC1

GUDID 05060483011233

The Technovent Magnacap System is a magnetic attachment system for implant retained craniofacial and dental prostheses.

TECHNOVENT LIMITED

Magnetic dental precision attachment

• Primary Device ID: 05060483011233
• NIH Device Record Key: db389cfa-7c4f-4e7f-8adc-8b9274341e2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ‘MagnaCap’ Magnetic Retention System
• Version Model Number: Mini Lab Analoge Cap - Vistafix Gen 3
• Catalog Number: VF-LAC1
• Company DUNS: 225835156
• Company Name: TECHNOVENT LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060483011233 [Primary]

FDA Product Code

• EGG: Attachment, Precision, All

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-30
• Device Publish Date: 2024-07-22

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