‘MagnaCap’ Magnetic Retention System B-LAC2-OR

GUDID 05060483010793

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: 05060483010793
• NIH Device Record Key: e457ce8e-799b-4ff3-94f2-5b3b07994ab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ‘MagnaCap’ Magnetic Retention System
• Version Model Number: Lab Analogue Auricular Cap - Vistafix Gen 2
• Catalog Number: B-LAC2-OR
• 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 *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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060483010793 [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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