Home GUDID 05060483013138 Prosthetic Silicone Materials
Primary DI 05060483013138
Brand Prosthetic Silicone Materials
Company TECHNOVENT LIMITED
Model AlSil Gum 80 Shore – 20kg
Catalog number AL80C
Device description Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials
Published 2024-07-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GBI Material, External Aesthetic Restoration, Used With Adhesive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GBI Material, External Aesthetic Restoration, Used With Adhesive General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060483013138 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060483013138 05060483013138 5060483013138
GMDN Terms# Term, Definition table Term Definition External limb prosthesis finishing component, custom-made A custom-made cosmetic component of an external upper or lower limb prosthesis designed to provide an aesthetic outer shape and surface to the prosthesis via one of various forms (e.g., foot shell, filler, skin, stocking, glove, limb cover) produced for a specific patient manually, or using computer-based anatomical imaging 3-D printing. It may be made of various materials (e.g., foam, thermoplast, wood, silicone, fibreglass, resin, carbon fibre), and may additionally be designed to protect the prosthesis from external agents (e.g., debris, water splashes, impact forces).
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date. Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 225835156 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060483010496 Magnabutments B-MA1-S Mini Magnabutment (Branemark) – S-Range B-MA1-S 2024-10-14 05060483010502 Magnabutments B-MA2-S Maxi Magnabutment (Branemark) – S-Range B-MA2-S 2024-10-14 05060483010519 Magnabutments E-MA1-S Mini Magnabutment (Cochlear Vistafix, hist E-MA1-S 2024-10-14 05060483010526 Magnabutments E-MA2-S Maxi Magnabutment (Cochlear Vistafix, hist E-MA2-S 2024-10-14 05060483010540 Magnabutments S-MA2-S Maxi Magnabutment (Straumann ITI) – S-Rang S-MA2-S 2024-10-14 05060483010601 Magnabutments P-MA1-5.0-S Mini Magnabutment (Medicon, 5.0mm) – S P-MA1-5.0-S 2024-10-14 05060483010625 Magnabutments P-MA2-1.6-S Maxi Magnabutment (Medicon, 1.6mm) – S P-MA2-1.6-S 2024-10-14 05060483010632 Magnabutments P-MA2-3.5-S Maxi Magnabutment (Medicon, 3.5mm) – S P-MA2-3.5-S 2024-10-14 05060483010649 Magnabutments P-MA2-5.0-S Maxi Magnabutment (Medicon, 5.0mm) – S P-MA2-5.0-S 2024-10-14 05060483010656 Magnabutments P-MA2-6.5-S Maxi Magnabutment (Medicon, 6.5mm) – S P-MA2-6.5-S 2024-10-14 05060483010663 Magnabutments IE-MA1-S Mini Magnabutment (Southern Implants) – S IE-MA1-S 2024-10-14 05060483010670 Magnabutments IE-MA2-S Maxi Magnabutment (Southern Implants) – S IE-MA2-S 2024-10-14 05060483010687 Magnabutments IT-MA1-S Mini Magnabutment (Southern Implants) – S IT-MA1-S 2024-10-14 05060483010694 Magnabutments IT-MA2-S Maxi Magnabutment (Southern Implants) – S IT-MA2-S 2024-10-14 05060483010700 Magnabutments HX-MA1-S Mini Magnabutment (Southern Implants) – S HX-MA1-S 2024-10-14 05060483010717 Magnabutments HX-MA2-S Maxi Magnabutment (Southern Implants) – S HX-MA2-S 2024-10-14 05060483010076 Prosthetic Adhesives ProBond Adhesive 37ml G609 2024-07-22 05060483010755 ‘MagnaCap’ Magnetic Retention System Mini Magnacap Astra Uni Abutment S-Range AMC1-S 2024-07-22 05060483010762 ‘MagnaCap’ Magnetic Retention System Maxi Magnacap Astra Uni Abutment S-Range AMC2-S 2024-07-22 05060483010779 ‘MagnaCap’ Magnetic Retention System Mini Magnacap - Lab Analogue B-LAC1 2024-07-22
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