Home GUDID 00812261016689 HYSTERO CATH
Primary DI 00812261016689
Brand HYSTERO CATH
Company ALLWIN MEDICAL DEVICES, INC.
Model HYSTERO CATH Hysterosalpingography Catheter Closed
Catalog number HC-HSG7
Device description HYSTERO CATH Hysterosalpingography Catheter Closed Tip
Published 2023-07-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name LKF Cannula, Manipulator/Injector, Uterine
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10812261016686 Package GS1 5 In Commercial Distribution 00812261016689 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 10812261016686 10812261016686 00812261016689 00812261016689 812261016689 0812261016689
GMDN Terms# Term, Definition table Term Definition Intrauterine imaging medium catheter A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.
Regulatory Flags# DUNS number 796354509 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00812261016597 ASPI ASPI Aspiration Needle ASPI22/30 2024-01-09 00819374021746 SURESTRIP SURESTRIP Vitrification Straw SUS-Y 2024-01-10 00812261010069 allSoft allSoft Ureteral Stent Open Tip SOT5/24 2024-01-09 00812261010823 allSoft allSoft Pediatric Ureteral Stents Open Tip 3F, 10c POS3/10 2024-01-09 00812261010830 allSoft allSoft Pediatric Ureteral Stents Open Tip 3F, 12c POS3/12 2024-01-09 00812261010847 allSoft allSoft Pediatric Ureteral Stents Open Tip 3F, 14c POS3/14 2024-01-09 00812261010854 allSoft allSoft Pediatric Ureteral Stents Open Tip 3F, 16c POS3/16 2024-01-09 00812261010861 allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 10c POS4/10 2024-01-09 00812261010878 allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 12c POS4/12 2024-01-09 00812261010885 allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 14c POS4/14 2024-01-09 00812261010892 allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 16c POS4/16 2024-01-09 00812261010908 allSoft allSoft Pediatric Ureteral Stents Open Tip 3F, 10c POS3/10-G 2024-01-09 00812261010915 allSoft allSoft Pediatric Ureteral Stents Open Tip 3F, 12c POS3/12-G 2024-01-09 00812261010922 allSoft allSoft Pediatric Ureteral Stents Open Tip 3F, 14c POS3/14-G 2024-01-09 00812261010939 allSoft allSoft Pediatric Ureteral Stents Open Tip 3F, 16c POS3-16-G 2024-01-09 00812261010946 allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 10c POS4/10-G 2024-01-09 00812261010953 allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 12c POS4/12-G 2024-01-09 00812261010960 allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 14c POS4/14-G 2024-01-09 00812261010977 allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 16c POS4/16-G 2024-01-09 00812261011806 allDrain allDrain Percutaneous Nephrostomy Catheter Pigtail PCN-P14 2024-01-09
Other Devices Sharing Product Codes# 
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