Home GUDID 30749756261341 DeRoyal
Primary DI 30749756261341
Brand DeRoyal
Company DEROYAL INDUSTRIES, INC.
Model 28-0602
Device description Pneumoperitoneum Needle
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FHO pneumoperitoneum needle
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FHO Pneumoperitoneum Needle Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30749756261341 Package GS1 10 In Commercial Distribution 50749756261345 Package GS1 40 In Commercial Distribution 00749756261340 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 30749756261341 30749756261341 50749756261345 50749756261345 00749756261340 00749756261340 749756261340 0749756261340
GMDN Terms# Term, Definition table Term Definition Spring-loaded pneumoperitoneum needle, single-use A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.
Regulatory Flags# DUNS number 096372255 Device count 1 DM exempt true Premarket exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06937845500607 GTK Guangzhou T.K Medical Instrument Co.,Ltd. FHO 2024-05-23 06937845500614 GTK Guangzhou T.K Medical Instrument Co.,Ltd. FHO 2024-05-23 00850059707005 AccuMedx Accumedx, LLC FHO 2024-01-23 00850059707012 AccuMedx Accumedx, LLC FHO 2024-01-23 00810143450545 MD EndoGuidance Laparoscopic Insufflator Medical Disposables Corp FHO 2023-07-31 00810143450750 MD EndoGuidance Laparoscopic Insufflator Medical Disposables Corp FHO 2023-07-31 00858690006990 INSUFFLATION NEEDLE,15CM RANFAC CORP. FHO 2018-03-02 20858690006994 INSUFFLATION NEEDLE,15CM RANFAC CORP. FHO 2018-03-02 04714127862026 Veress Needle UNIMAX MEDICAL SYSTEMS INC. FHO 2017-06-19 00821925002616 THL Gyrus ACMI, LLC FHO 2017-05-11 00858690006204 INSUFFLATION NEEDLE,12CM RANFAC CORP. FHO 2017-05-08 20858690006208 INSUFFLATION NEEDLE,12CM RANFAC CORP. FHO 2017-05-08 04714127862002 Veress Needle UNIMAX MEDICAL SYSTEMS INC. FHO 2017-01-09 24714127862006 Veress Needle UNIMAX MEDICAL SYSTEMS INC. FHO 2017-01-09 06955797740018 Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd. FHO 2016-12-22 06955797740025 Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd. FHO 2016-12-22 16955797740015 Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd. FHO 2016-12-22 16955797740022 Unimicro Unimicro Medical Systems (ShenZhen) Co., Ltd. FHO 2016-12-22 20884521080819 Surgineedle Covidien LP FHO 2016-10-20 10884521080812 Surgineedle Covidien LP FHO 2016-10-20 00821925001527 USA Series Gyrus ACMI, LLC FHO 2016-10-14 00821925008915 USA Series Gyrus ACMI, LLC FHO 2016-10-14 04055207039755 NA Richard Wolf GmbH FHO 2016-09-27 04055207043097 NA Richard Wolf GmbH FHO 2016-09-27 04055207043103 NA Richard Wolf GmbH FHO 2016-09-27 04055207057988 NA Richard Wolf GmbH FHO 2016-09-27 04055207057995 NA Richard Wolf GmbH FHO 2016-09-27 10884521080805 Surgineedle Covidien LP FHO 2016-09-24 20653405046032 CORE DYNAMICS Conmed Corporation FHO 2016-09-24 20653405046049 CORE DYNAMICS Conmed Corporation FHO 2016-09-24
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