Home GUDID 20888937003592 Select IUI
Primary DI 20888937003592
Brand Select IUI
Company Coopersurgical, Inc.
Model SM400
Device description Intrauterine Insemination Catheter
Published 2016-08-09
Public version status Update
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 MFD Cannula, Intrauterine Insemination
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MFD Cannula, Intrauterine Insemination Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20888937003592 Package GS1 25 In Commercial Distribution 00888937003598 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 20888937003592 20888937003592 00888937003598 00888937003598 888937003598 0888937003598
GMDN Terms# Term, Definition table Term Definition Assisted reproduction transfer catheter/set A device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.
Regulatory Flags# DUNS number 801895244 Device count 1 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 00812261016603 Insemina Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00812261016610 Stumpy Intra Uterine Insemination Cannula ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00812261016818 Curved Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00812261016825 Flexi Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00812261016863 Trackable Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00819374021814 Insemina Open Tip Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00819374021890 Curved Insemina Intra Uterine Insemination Catheter Open Tip ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00819374022019 Trackable Intra Uterine Insemination Catheter Open Tip ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00819374022491 Flexi Intra Uterine Insemination Catheter Open Tip ALLWIN MEDICAL DEVICES, INC. MFD 2020-09-18 00888937021332 Wallace Artificial Insemination Catheter Coopersurgical, Inc. MFD 2019-09-26 30888937021333 Wallace Artificial Insemination Catheter Coopersurgical, Inc. MFD 2019-09-26 35019315071533 Pneupac ICU MEDICAL, INC. MFD 2017-01-03 15019315015700 Wallace ICU MEDICAL, INC. MFD 2016-10-05 35019315015704 Wallace Smiths Medical International Ltd MFD 2016-10-05 00827002169449 Insemi-Cath COOK INCORPORATED MFD 2016-09-24 00827002169616 Insemi-Cath COOK INCORPORATED MFD 2016-09-24 00827002173439 Insemi-Cath COOK INCORPORATED MFD 2016-09-24 00827002189522 Cook COOK INCORPORATED MFD 2016-09-24 10827002167077 Insemi-Cath COOK INCORPORATED MFD 2016-09-24 10827002167862 Insemi-Cath COOK INCORPORATED MFD 2016-09-24 10827002169446 Insemi-Cath COOK INCORPORATED MFD 2016-09-24 10827002169613 Insemi-Cath COOK INCORPORATED MFD 2016-09-24 10827002173436 Insemi-Cath COOK INCORPORATED MFD 2016-09-24 00827002179127 Soft-Pass COOK INCORPORATED MFD 2016-09-24 00827002181830 Soft-Pass COOK INCORPORATED MFD 2016-09-24 00827002181908 Soft-Pass COOK INCORPORATED MFD 2016-09-24 10827002189529 Cook COOK INCORPORATED MFD 2016-09-24 10827002189536 Cook COOK INCORPORATED MFD 2016-09-24 00827002190849 Soft-Pass COOK INCORPORATED MFD 2016-09-24 00827002191297 Soft-Pass COOK INCORPORATED MFD 2016-09-24