Home GUDID 00840286844000 UniSyn Hip System
Primary DI 00840286844000
Brand UniSyn Hip System
Company Shalby Advanced Technologies, Inc.
Model 4430-10000-A
Catalog number 4430-10000-A
Device description Circular Osteotome, UniSyn
Published 2025-05-14
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 GFI Osteotome, Manual
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GFI Osteotome, Manual General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840286844000 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 00840286844000 00840286844000 840286844000 0840286844000
GMDN Terms# Term, Definition table Term Definition Orthopaedic osteotome A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 085976260 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840286860147 Tahoe Unicompartmental Knee System 3000-0-1701 3000-0-1701 2026-07-10 00840286860154 Tahoe Unicompartmental Knee System 3000-0-1702 3000-0-1702 2026-07-10 00840286860161 Tahoe Unicompartmental Knee System 3000-0-1703 3000-0-1703 2026-07-10 00840286860178 Tahoe Unicompartmental Knee System 3000-0-1704 3000-0-1704 2026-07-10 00840286860185 Tahoe Unicompartmental Knee System 3000-0-1705 3000-0-1705 2026-07-10 00840286860192 Tahoe Unicompartmental Knee System 3000-0-1706 3000-0-1706 2026-07-10 00840286860208 Tahoe Unicompartmental Knee System 3000-0-1707 3000-0-1707 2026-07-10 00840286860215 Tahoe Unicompartmental Knee System 3000-0-1708 3000-0-1708 2026-07-10 00840286860239 Tahoe Unicompartmental Knee System 3000-0-1602 3000-0-1602 2026-07-10 00840286860246 Tahoe Unicompartmental Knee System 3000-0-1603 3000-0-1603 2026-07-10 00840286860253 Tahoe Unicompartmental Knee System 3000-0-1604 3000-0-1604 2026-07-10 00840286860260 Tahoe Unicompartmental Knee System 3000-0-1605 3000-0-1605 2026-07-10 00840286860277 Tahoe Unicompartmental Knee System 3000-0-1606 3000-0-1606 2026-07-10 00840286860284 Tahoe Unicompartmental Knee System 3000-0-1607 3000-0-1607 2026-07-10 00840286860291 Tahoe Unicompartmental Knee System 3000-0-1608 3000-0-1608 2026-07-10 00840286860307 Tahoe Unicompartmental Knee System 3600-0-0000 3600-0-0000 2026-07-10 00840286860314 Tahoe Unicompartmental Knee System 3600-0-0001 3600-0-0001 2026-07-10 00840286860321 Tahoe Unicompartmental Knee System 3600-0-0002 3600-0-0002 2026-07-10 00840286860338 Tahoe Unicompartmental Knee System 3600-0-0003 3600-0-0003 2026-07-10 00840286860345 Tahoe Unicompartmental Knee System 3600-0-0004 3600-0-0004 2026-07-10
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