Prosthetic Silicone Materials M518

GUDID 05060483012476

Cartridge based silicone materials for taking external impressions to aid the construction of prostheses.

TECHNOVENT LIMITED

Silicone dental impression material

• Primary Device ID: 05060483012476
• NIH Device Record Key: c94a9465-89b4-4860-8ec5-bfc1f2c644c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosthetic Silicone Materials
• Version Model Number: CoForm Hard Impression Material – 40g
• Catalog Number: M518
• Company DUNS: 225835156
• Company Name: TECHNOVENT LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

• Special Storage Condition, Specify: Between 0 and 0 *The Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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 Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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	05060483012476 [Primary]

FDA Product Code

• GBI: Material, External Aesthetic Restoration, Used With Adhesive

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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