Home GUDID D6911030840 Premier
Primary DI D6911030840
Brand Premier
Company PREMIER DENTAL PRODUCTS COMPANY
Model 1030840
Device description CANNULA JARCHO SELF-RETAINING
Published 2016-09-16
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 HIG Insufflator, Hysteroscopic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HIG Insufflator, Hysteroscopic Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D6911030840 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Hysteroscopic irrigation/insufflation system A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 014789663 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 00191506023348 Asurys™ BOSTON SCIENTIFIC CORPORATION HIG 2026-04-03 00191506047962 Asurys™ BOSTON SCIENTIFIC CORPORATION HIG 2026-04-03 00850006759835 Aveta Tissue Catch with Tubing MEDITRINA, INC. HIG 2026-03-20 00850033976342 Symphion Operative Hysteroscopy System Prime Controller- Refurbished Minerva Surgical, Inc. HIG 2026-02-13 03700111401099 RIGISTER CUPULE 20 mm LABORATOIRE CCD HIG 2025-11-27 03700111401105 RIGISTER CUPULE 25 mm LABORATOIRE CCD HIG 2025-11-27 03700111401112 RIGISTER CUPULE 30 mm LABORATOIRE CCD HIG 2025-11-27 03700111401129 RIGISTER CUPULE 35 mm LABORATOIRE CCD HIG 2025-11-27 03700111401136 SLIDING RIGISTER CUPULE 20 mm LABORATOIRE CCD HIG 2025-11-27 03700111401143 SLIDING RIGISTER CUPULE 25 mm LABORATOIRE CCD HIG 2025-11-27 03700111401150 SLIDING RIGISTER CUPULE 30 mm LABORATOIRE CCD HIG 2025-11-27 03700111401167 SLIDING RIGISTER CUPULE 35 mm LABORATOIRE CCD HIG 2025-11-27 00850033976335 Symphion Operative Hysteroscopy System Prime Controller Minerva Surgical, Inc. HIG 2025-10-31 00850006759811 Aveta Drape Pump MEDITRINA, INC. HIG 2025-04-11 07613327626391 ThermaClear STRYKER CORPORATION HIG 2025-04-04 07613327626407 ThermaClear STRYKER CORPORATION HIG 2025-04-04 04048551377567 NA Karl Storz GmbH & Co. KG HIG 2025-03-27 00821925002630 Gyrus ACMI Gyrus ACMI, LLC HIG 2024-12-09 25420045516110 Fluent Pro Waste Bag Hologic, Inc. HIG 2024-10-15 25420045516134 Fluent Pro Tissue Trap Hologic, Inc. HIG 2024-10-15 15420045516144 Fluent Pro Procedure Kit Hologic, Inc. HIG 2024-10-15 00850006759699 Aveta Waste Management Accessory MEDITRINA, INC. HIG 2024-10-14 00850006759736 Aveta Waste Bag with Tissue Catch MEDITRINA, INC. HIG 2024-10-14 00850033976243 Symphion Fluid Deficit Readout Minerva Surgical, Inc. HIG 2024-08-12 15420045516212 Fluent Pro Fluid Management System Hologic, Inc. HIG 2024-08-06 04056702012861 GYN-Pump W.O.M. World of Medicine GmbH HIG 2024-06-28 04056702012878 Fluid Monitoring Unit W.O.M. World of Medicine GmbH HIG 2024-06-28 00850006759460 Aveta Smol Disposable Resecting Device, 2.9 mm MEDITRINA, INC. HIG 2024-04-26 00850006759484 Aveta Smol Disposable Resecting Device, 2.9 mm MEDITRINA, INC. HIG 2024-04-26 00850006759613 Aveta Smol Disposable Resecting Device, 2.9 mm MEDITRINA, INC. HIG 2024-04-26