Home GUDID 00819374021524 Twinkle Embryo Trans Embryo Transfer Catheter (23cm)
Primary DI 00819374021524
Brand Twinkle Embryo Trans Embryo Transfer Catheter (23cm)
Company ALLWIN MEDICAL DEVICES, INC.
Model Twinkle Embryo Trans (23cm)
Catalog number TEB-ETC23
Device description Twinkle Embryo Trans Embryo Transfer Catheter 23cm
Published 2020-09-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MQF Catheter, Assisted Reproduction
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQF Catheter, Assisted Reproduction Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10819374021521 Package GS1 10 In Commercial Distribution 00819374021524 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 10819374021521 10819374021521 00819374021524 00819374021524 819374021524 0819374021524
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 796354509 Device count 1 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
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