Home GUDID 00819034028894
Sgarlato Silastic
Primary DI 00819034028894
Brand Sgarlato Silastic
Company FUSION ORTHOPEDICS, LLC
Model 90-301-20
Catalog number 90-301-20
Device description SHIP Long/Shaw Drill Flexible
Published 2020-11-20
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 00819034028894 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 00819034028894 00819034028894 819034028894 0819034028894
GMDN Terms# Term, Definition table Term Definition Cannulated surgical drill bit, single-use, non-sterile A non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device intended to be sterilized prior to use.
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