Home GUDID 09348215146955 Rx Knee AP Symmetrical Augment Size 9 - 12mm Poly Half Draft Left
Primary DI 09348215146955
Brand Rx Knee AP Symmetrical Augment Size 9 - 12mm Poly Half Draft Left
Company SIGNATURE ORTHOPAEDICS PTY LTD
Model 121-20-9379
Published 2025-03-19
Public version status Update
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 JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09348215146955 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09348215146955 09348215146955 9348215146955
GMDN Terms# Term, Definition table Term Definition Temporary knee prosthesis, non-customized A prefabricated, implantable device that includes a pharmaceutical antibiotic agent (e.g., gentamicin) intended to be used as a temporary substitute for a knee prosthesis to: 1) provide a means for limited mobility/weight-bearing; and 2) release the antibiotic agent to the periprosthetic space to treat infection as part of a revision orthopaedic surgery. Also known as a spacer, it may include knee femur and/or tibial components, and is made of metallic and/or polymer materials. Following infection treatment and device explantation, a definitive prosthesis is implanted.
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 09348215185428 Signature Magnum Acetabular Cup 111-67-0044 2026-07-29 09348215185435 Signature Magnum Acetabular Cup 111-67-0046 2026-07-29 09348215185442 Signature Magnum Acetabular Cup 111-67-0048 2026-07-29 09348215185459 Signature Magnum Acetabular Cup 111-67-0050 2026-07-29 09348215185466 Signature Magnum Acetabular Cup 111-67-0052 2026-07-29 09348215185473 Signature Magnum Acetabular Cup 111-67-0054 2026-07-29 09348215185480 Signature Magnum Acetabular Cup 111-67-0056 2026-07-29 09348215185497 Signature Magnum Acetabular Cup 111-67-0058 2026-07-29 09348215185503 Signature Magnum Acetabular Cup 111-67-0060 2026-07-29 09348215185510 Signature Magnum Acetabular Cup 111-67-0062 2026-07-29 09348215185527 Signature Magnum Acetabular Cup 111-67-0064 2026-07-29 09348215185534 Signature Magnum Acetabular Cup 111-67-0066 2026-07-29 09348215185541 Signature Resurfacing Femoral Head 111-67-0138 2026-07-29 09348215185558 Signature Resurfacing Femoral Head 111-67-0140 2026-07-29 09348215185565 Signature Resurfacing Femoral Head 111-67-0142 2026-07-29 09348215185572 Signature Resurfacing Femoral Head 111-67-0144 2026-07-29 09348215185589 Signature Resurfacing Femoral Head 111-67-0146 2026-07-29 09348215185596 Signature Resurfacing Femoral Head 111-67-0148 2026-07-29 09348215185602 Signature Resurfacing Femoral Head 111-67-0150 2026-07-29 09348215185619 Signature Resurfacing Femoral Head 111-67-0152 2026-07-29
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