Home GUDID 09348215134549
Nebula Standard Offset Size 3
Primary DI 09348215134549
Brand Nebula Standard Offset Size 3
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 111-59-0003
Published 2025-03-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KWL Prosthesis, Hip, Hemi-, Femoral, Metal KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic 2 KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2 KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic 2 LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic 2 LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic 2 MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic 2 OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic 2 OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215134549 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215134549 09348215134549 9348215134549
GMDN Terms# Term, Definition table Term Definition Coated hip femur prosthesis, modular A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
Regulatory Flags# DUNS number 751993028 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09348215158828 World Knee MC Poly Insert - Size 8 - 10mm, Left 121-20-7890L 2026-06-09 09348215158835 World Knee MC Poly Insert - Size 8 - 11mm, Left 121-20-7891L 2026-06-09 09348215158842 World Knee MC Poly Insert - Size 8 - 12mm, Left 121-20-7892L 2026-06-09 09348215158859 World Knee MC Poly Insert - Size 8 - 13mm, Left 121-20-7893L 2026-06-09 09348215158866 World Knee MC Poly Insert - Size 8 - 14mm, Left 121-20-7894L 2026-06-09 09348215158873 World Knee MC Poly Insert - Size 8 - 15mm, Left 121-20-7895L 2026-06-09 09348215158880 World Knee MC Poly Insert - Size 8 - 16mm, Left 121-20-7896L 2026-06-09 09348215158897 World Knee MC Poly Insert - Size 8 - 17mm, Left 121-20-7897L 2026-06-09 09348215158903 World Knee MC Poly Insert - Size 8 - 18mm, Left 121-20-7898L 2026-06-09 09348215158910 World Knee MC Poly Insert - Size 8 - 10mm, Right 121-20-7890R 2026-06-09 09348215158927 World Knee MC Poly Insert - Size 8 - 11mm, Right 121-20-7891R 2026-06-09 09348215158934 World Knee MC Poly Insert - Size 8 - 12mm, Right 121-20-7892R 2026-06-09 09348215158941 World Knee MC Poly Insert - Size 8 - 13mm, Right 121-20-7893R 2026-06-09 09348215158958 World Knee MC Poly Insert - Size 8 - 14mm, Right 121-20-7894R 2026-06-09 09348215158965 World Knee MC Poly Insert - Size 8 - 15mm, Right 121-20-7895R 2026-06-09 09348215158972 World Knee MC Poly Insert - Size 8 - 16mm, Right 121-20-7896R 2026-06-09 09348215158989 World Knee MC Poly Insert - Size 8 - 17mm, Right 121-20-7897R 2026-06-09 09348215158996 World Knee MC Poly Insert - Size 8 - 18mm, Right 121-20-7898R 2026-06-09 09348215160265 World Knee MC Vit-E Poly Insert - Size 7 - 10mm, Left 121-20-7790LE 2026-06-09 09348215160272 World Knee MC Vit-E Poly Insert - Size 7 - 11mm, Left 121-20-7791LE 2026-06-09
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