Home GUDID 00190776157685 Depuy Synthes
Primary DI 00190776157685
Brand Depuy Synthes
Company Avalign Technologies, Inc.
Model 60.045.054
Device description Advanced Reaming System - Standard Outlier - Base
Published 2020-10-05
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 FSM Tray, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776157685 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 00190776157685 00190776157685 190776157685 0190776157685
GMDN Terms# Term, Definition table Term Definition Instrument tray A container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. 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 Manufacturing date on label 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 B382SD923300150 Surgical Direct Surgical Direct, Inc. FSM 2026-08-07 B382SD923301040 Surgical Direct Surgical Direct, Inc. FSM 2026-08-07 00840606192002 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192019 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192026 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192033 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192040 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194884 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194891 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194907 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194914 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194921 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194938 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194945 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194952 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194969 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194976 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194983 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194990 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195003 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195010 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195027 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195034 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195041 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195058 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195065 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195539 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195669 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195676 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195683 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31