Home GUDID 09349967000854 HolstOR
Primary DI 09349967000854
Brand HolstOR
Company THE O R COMPANY PTY LTD
Model H-250
Published 2020-01-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MDM Instrument, Manual, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 09349967000854 Package GS1 25 In Commercial Distribution 09349967000847 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09349967000854 09349967000854 9349967000854 09349967000847 09349967000847 9349967000847
GMDN Terms# Term, Definition table Term Definition Electrosurgical handpiece/electrode holder, single-use A device intended to be used to house or fix an active electrosurgical handpiece/pen with its electrode when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. The holder will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a single-use device.
Regulatory Flags# DUNS number 744346235 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09349967002759 Uterine ElevatOR Pro UE-TVPRO-32 2018-01-31 09349967002780 Uterine ElevatOR Pro UE-TVPRO-35 2018-01-31 09349967002810 Uterine ElevatOR Pro UE-TVPRO-37 2018-01-31 09349967002841 Uterine ElevatOR Pro UE-TVPRO-40 2018-01-31 09349967003268 Lap Scope WarmOR SW-5-10-R 2019-03-27 09349967003442 ColpotomizOR Tube System CTS35-TV 2019-03-27 09349967003473 ColpotomizOR Tube System CTS45-TV 2019-03-27 09349967004036 Skin MarkOR Fine Tip SMOR-F 2021-04-12 09349967004067 Skin MarkOR Regular Tip SMOR-R 2021-04-12 09349967004210 Laparoscopic Smoke Evacuator LSE-01 2021-04-12 09349967004968 Uterine ElevatOR PRO with OccludOR Balloon™ UE-OBPRO-35NT UE-OBPRO-35NT 2023-05-26 09349967004975 Uterine ElevatOR PRO with OccludOR Balloon™ UE-OBPRO-37NT UE-OBPRO-37NT 2023-05-26 09349967004982 Uterine ElevatOR PRO with OccludOR Balloon™ UE-OBPRO-40NT UE-OBPRO-40NT 2023-05-26 09349967005019 Uterine ElevatOR PRO with OccludOR Balloon™ UE-OBPRO-32NT UE-OBPRO-32NT 2023-05-26 09349967005064 Uterine ElevatOR PRO with Long Handle™ UE-LHPRO-32NT UE-LHPRO-32NT 2023-05-26 09349967005071 Uterine ElevatOR PRO with Long Handle™ UE-LHPRO-35NT UE-LHPRO-35NT 2023-05-26 09349967005088 Uterine ElevatOR PRO with Long Handle™ UE-LHPRO-37NT UE-LHPRO-37NT 2023-05-26 09349967005095 Uterine ElevatOR PRO with Long Handle™ UE-LHPRO-40NT UE-LHPRO-40NT 2023-05-26 09349967005101 Uterine PositionOR PRO™ UE-PLH-NT UE-PLH-NT 2023-05-26 19349967004965 Uterine ElevatOR PRO with OccludOR Balloon™ UE-OBPRO-35NT UE-OBPRO-35NT 2023-05-26
Other Devices Sharing Product Codes#