Home GUDID 00840124506138 Sgarlato Silastic
Primary DI 00840124506138
Brand Sgarlato Silastic
Company FUSION ORTHOPEDICS, LLC
Model 80-099-02
Catalog number 80-099-02
Device description SHIP Long Sizer Flexible
Published 2021-08-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KWH Prosthesis, Toe, Constrained, Polymer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWH Prosthesis, Toe, Constrained, Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840124506138 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840124506138 00840124506138 840124506138 0840124506138
GMDN Terms# Term, Definition table Term Definition Total metatarsophalangeal joint prosthesis, one-piece An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080307067 Device count 1 DM exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00819034029181 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2023-07-14 00819034029198 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2023-07-14 00819034029211 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2023-07-14 00840124507456 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2023-07-14 00840124508989 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2023-07-14 00885556834244 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834268 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834282 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834305 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834329 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834374 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834398 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834411 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834435 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834534 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834558 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834572 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 00885556834596 Silicone Toe System Smith & Nephew, Inc. KWH 2022-12-22 08057717550801 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550818 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550825 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550832 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550849 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550856 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550863 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550870 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550887 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 08057717550894 Silktoe Spacer BRM EXTREMITIES SRL KWH 2021-10-17 00840124506145 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2021-08-18 00840124506152 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2021-08-18