Home GUDID 00846832006526 Futura™ FDI
Primary DI 00846832006526
Brand Futura™ FDI
Company TORNIER, INC.
Model FDI-05
Published 2015-10-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile 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 00846832006526 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 00846832006526 00846832006526 846832006526 0846832006526
GMDN Terms# Term, Definition table Term Definition Total metatarsophalangeal joint prosthesis, one-piece A sterile 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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 968990812 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false 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 00840124506138 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2021-08-18 00840124506145 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2021-08-18
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