Home GUDID 08800075626349 OSUNG MND
Primary DI 08800075626349
Brand OSUNG MND
Company OSUNG MND Co., Ltd.
Model SBA18T2
Device description A non-sterile, hand-held manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.
Published 2024-02-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name EJI Syringe, Cartridge
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EJI Syringe, Cartridge Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800075626349 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800075626349 08800075626349 8800075626349
GMDN Terms# Term, Definition table Term Definition Dental impression material syringe, reusable A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 688207479 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00840326422663 Astek Young Innovations, Inc. EJI 2025-05-27 00840326423684 Astek Young Innovations, Inc. EJI 2025-05-27 00840326423721 Astek Young Innovations, Inc. EJI 2025-05-27 05713513001185 ASPIJECT Active Compact Rønvig Dental Manufacturing A/S EJI 2025-02-27 05060212057518 Dental Syringe 85mm, for 2.2ml vial DTR MEDICAL LIMITED EJI 2024-10-11 05060212057525 Dental Syringe Long 115mm, for 2.2ml vial DTR MEDICAL LIMITED EJI 2024-10-11 00813677022882 PDT, Inc. PDT, INC. EJI 2024-07-01 00813677022905 PDT, Inc. PDT, INC. EJI 2024-07-01 00813677022899 PDT, Inc. PDT, INC. EJI 2024-06-27 08800075607799 OSUNG MND OSUNG MND Co., Ltd. EJI 2024-03-05 08800075614391 OSUNG MND OSUNG MND Co., Ltd. EJI 2024-03-05 08800075614407 OSUNG MND OSUNG MND Co., Ltd. EJI 2024-03-05 08800075614421 OSUNG MND OSUNG MND Co., Ltd. EJI 2024-03-05 08800075624994 OSUNG MND OSUNG MND Co., Ltd. EJI 2024-03-05 08800075607812 OSUNG MND OSUNG MND Co., Ltd. EJI 2024-02-23 08800075626332 OSUNG MND OSUNG MND Co., Ltd. EJI 2024-02-23 08800075626356 OSUNG MND OSUNG MND Co., Ltd. EJI 2024-02-23 08800053042093 DENOPS DENTIS CO. ,LTD EJI 2024-01-23 00840326421741 Astek Young Innovations, Inc. EJI 2023-12-01 00840326421758 Astek Young Innovations, Inc. EJI 2023-12-01 20840326421769 Astek Young Innovations, Inc. EJI 2023-12-01 10840326421779 Astek Young Innovations, Inc. EJI 2023-12-01 10840326421786 Astek Young Innovations, Inc. EJI 2023-12-01 20840326421790 Astek Young Innovations, Inc. EJI 2023-12-01 10840326421809 Astek Young Innovations, Inc. EJI 2023-12-01 20840326421813 Astek Young Innovations, Inc. EJI 2023-12-01 20840326421820 Astek Young Innovations, Inc. EJI 2023-12-01 10840326421830 Astek Young Innovations, Inc. EJI 2023-12-01 10840326421847 Astek Young Innovations, Inc. EJI 2023-12-01 20840326421851 Astek Young Innovations, Inc. EJI 2023-12-01