Home GUDID 05060183095793 Osteotec SFI Instruments
Primary DI 05060183095793
Brand Osteotec SFI Instruments
Company OSTEOTEC LIMITED
Model OSTF-Ins
Catalog number OSTF-Ins
Device description The Osteotec SFI Instruments device are a non-active, non-implantable, invasive device intended to be used as a tool for creating the correct size of cavity in the medullary canal to enable implantation of the Osteotec Silicone Finger Implant prosthesis during arthroplasty to replace the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints.The Osteotec SFI Instruments are available in eleven evenly scaled sizes, numbered from size 00 to size 9, to match the available sizes of the definitive implant, the Osteotec Silicone Finger Implant. Each size has 2 rasps, one for creation of the proximal cavity and one for the distal cavity, therefore 22 rasps in total. The instrument set also includes an Awl, this creates an initial indent for the rasps to open up in stages. These eleven sizes and the Awl effectively constitute components of the Osteotec SFI Instruments, which is placed on the market as a single medical device.
Published 2025-11-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060183095793 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060183095793 05060183095793 5060183095793
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 348489386 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060183095809 Osteotec SFI Sizer OSTF-Sizer OSTF-Sizer 2025-11-26 05060183090002 Osteotec Silicone Finger Implant - Size 00 OSTF-00 OSTF-00 2022-02-04 05060183090019 Osteotec Silicone Finger Implant - Size 0 OSTF-0 OSTF-0 2022-02-04 05060183090026 Osteotec Silicone Finger Implant - Size 1 OSTF-1 OSTF-1 2022-02-04 05060183090033 Osteotec Silicone Finger Implant - Size 2 OSTF-2 OSTF-2 2022-02-04 05060183090040 Osteotec Silicone Finger Implant - Size 3 OSTF-3 OSTF-3 2022-02-04 05060183090057 Osteotec Silicone Finger Implant - Size 4 OSTF-4 OSTF-4 2022-02-04 05060183090064 Osteotec Silicone Finger Implant - Size 5 OSTF-5 OSTF-5 2022-02-04 05060183090071 Osteotec Silicone Finger Implant - Size 6 OSTF-6 OSTF-6 2022-02-04 05060183090088 Osteotec Silicone Finger Implant - Size 7 OSTF-7 OSTF-7 2022-02-04 05060183090095 Osteotec Silicone Finger Implant - Size 8 OSTF-8 OSTF-8 2022-02-04 05060183090101 Osteotec Silicone Finger Implant - Size 9 OSTF-9 OSTF-9 2022-02-04 05060183095595 Osteotec CBG Tube Saw S - size 1 OST-CBG-01 OST-CBG-01 2022-02-04 05060183095601 Osteotec CBG Tube Saw S - size 2 OST-CBG-02 OST-CBG-02 2022-02-04 05060183095618 Osteotec CBG Tube Saw S - size 3 OST-CBG-03 OST-CBG-03 2022-02-04 05060183095625 Osteotec CBG Tube Saw S - size 4 OST-CBG-04 OST-CBG-04 2022-02-04 05060183095632 Osteotec CBG Tube Saw L - size 5 OST-CBG-05 OST-CBG-05 2022-02-04 05060183095649 Osteotec CBG Tube Saw L - size 6 OST-CBG-06 OST-CBG-06 2022-02-04 05060183095656 Osteotec CBG Tube Saw L - size 7 OST-CBG-07 OST-CBG-07 2022-02-04 05060183095663 Osteotec CBG Tube Saw L - size 8 OST-CBG-08 OST-CBG-08 2022-02-04
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