Home GUDID 00190776028299 Depuy Synthes
Primary DI 00190776028299
Brand Depuy Synthes
Company Avalign Technologies, Inc.
Model 03.520.021
Device description Osteotome, Epker Style, 4mm
Published 2017-12-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EMM Chisel, Osteotome, Surgical HWM Osteotome
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMM Chisel, Osteotome, Surgical Dental 1 HWM Osteotome General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776028299 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 00190776028299 00190776028299 190776028299 0190776028299
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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 Device count 1 Premarket exempt true Lot or batch 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 00810143904666 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143904673 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143907261 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143907278 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143907308 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810143907315 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930008 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930015 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930022 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930039 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930046 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930053 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930060 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930077 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930084 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930091 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930107 SURGIPROS Surgipros, LLC HWM 2026-06-01 00810212930114 SURGIPROS Surgipros, LLC HWM 2026-06-01 09348811099624 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 09348811110442 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 09348811111289 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 10381780503316 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503323 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503330 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503347 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503354 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 ESAM13290011 STOMA® Storz am Mark GmbH EMM 2020-08-27 ESAM13290021 STOMA® Storz am Mark GmbH EMM 2020-08-27 ESAM13290031 STOMA® Storz am Mark GmbH EMM 2020-08-27 ESAM13290041 STOMA® Storz am Mark GmbH EMM 2020-08-27
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