Home GUDID 00819374021548 Twinkle Pro
Primary DI 00819374021548
Brand Twinkle Pro
Company ALLWIN MEDICAL DEVICES, INC.
Model Twinkle Pro Embryo Transfer Catheter
Catalog number TPEB-ETC
Device description Twinkle Pro Embryo Transfer Catheter
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 10819374021545 Package GS1 10 In Commercial Distribution 00819374021548 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 10819374021545 10819374021545 00819374021548 00819374021548 819374021548 0819374021548
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
Other Devices Sharing Product Codes# 
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