Home GUDID 00819034028801 Sgarlato Silastic
Primary DI 00819034028801
Brand Sgarlato Silastic
Company FUSION ORTHOPEDICS, LLC
Model 30-301-01
Catalog number 30-301-01
Device description GAIT Broach (Lined) Distal
Published 2020-11-19
Public version status Update
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 00819034028801 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 00819034028801 00819034028801 819034028801 0819034028801
GMDN Terms# Term, Definition table Term Definition Bone-resection orthopaedic reamer, single-use An orthopaedic surgical instrument intended to resect bone (cut out part of the bone) and precisely shape a specific area of bone to accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); some types may, in addition, be designed to be used endoscopically to resect hypertrophic tissue [e.g., ligamentum flavum] to relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.
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 00840124506138 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2021-08-18 00840124506145 Sgarlato Silastic FUSION ORTHOPEDICS, LLC KWH 2021-08-18