Home GUDID GYNX31350 Gynex
Primary DI GYNX31350
Brand Gynex
Company GYNEX CORPORATION
Model 3135
Published 2023-12-26
Public version status New
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 HHI System, Abortion, Vacuum
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HHI System, Abortion, Vacuum Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status GYNX31351 Primary HIBCC 0 GYNX31350 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Endometrial biopsy kit A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.
Regulatory Flags# DUNS number 012997685 Device count 24 DM exempt false 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 GYNX31301 Gynex GYNEX CORPORATION HHI 2023-12-26 GYNX31351 Gynex GYNEX CORPORATION HHI 2023-12-26 GYNX31300 Gynex GYNEX CORPORATION HHI 2023-12-26 04055207040027 NA Richard Wolf GmbH HHI 2022-10-27 M803022721 MedGyn Pipette MEDGYN PRODUCTS, INC. HHI 2020-12-14 M803022730 MedGyn Pipette IV MEDGYN PRODUCTS, INC. HHI 2020-12-14 M803022734 MedGyn Pipette II MEDGYN PRODUCTS, INC. HHI 2020-12-14 00821925030862 Gyrus ACMI Gyrus ACMI, LLC HHI 2017-05-10 00821925000247 003997-901 Gauze Sack and O-Ring Gyrus Acmi, Inc. HHI 2017-05-10 00821925009561 GYRUS ACMI Gyrus ACMI, LLC HHI 2017-05-09 00821925010475 BERKELEY Gyrus ACMI, LLC HHI 2016-10-18 00821925008632 Berkeley 1/2" Collection Set Gyrus Acmi, Inc. HHI 2016-10-13 00821925008625 BERKELEY 1/2" (13mm) PRIMARY Gyrus Acmi, Inc. HHI 2016-10-13 00821925004184 Collection Set, Disposable with Handle and Tapered Fitting Tubing 6 f Gyrus Acmi, Inc. HHI 2016-10-11 00821925000919 VACURETTE CURVED 8MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925000940 21163 Permeable Gauze Sacks (10/Pkg) Gyrus Acmi, Inc. HHI 2016-10-11 00821925000964 VACURETTE STRAIGHT 9MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925000971 VACURETTE STRAIGHT 10MM 10PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925000988 VACURETTE STRAIGHT 11MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925000995 VACURETTE STRAIGHT 12MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925001015 VACURETTE CURVED 9MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925001022 VACURETTE CURVED 10MM Gyrus Acmi, Inc. HHI 2016-10-11 00821925001039 VACURETTE CURVED 11MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925001046 VACURETTE CURVED 12MM-10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925004689 VACURETTE STRAIGHT 16MM 10/PK Gyrus Acmi, Inc. HHI 2016-10-11 00821925004702 VACURETTE CURVED 16MM 10/PK Gyrus Acmi, Inc. HHI 2016-10-11 00821925004719 VACURETTE STRAIGHT 8MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925004726 VACURETTE "F" TIP 4MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925004597 VACURETTE "F" TIP 5MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11 00821925004603 VACURETTE "F" TIP 6MM 10/PKG Gyrus Acmi, Inc. HHI 2016-10-11