Sinton Medical Products

Basic Information

• Brand Name: Sinton Medical Products
• Primary DI: 06938327909512
• Version / Model: 400202-10
• Catalog Number: HT-LY1502CF
• Company Name: Shenzhen Boon Medical Supply Co., Ltd.
• Labeler DUNS: 529174252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-13
• Public Version: 1
• Public Version Date: 2021-11-22
• Public Version Status: New
• Public Device Record Key: b7b492f9-29b8-4531-ad60-a8f80123e6bf
• Distribution End Date: 9999-12-31

Device Description

1- 60"(1500mm) Y Coiled Tubing with Dual Check Valves(DEHP-free)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16938327909519	GS1	box	50	In Commercial Distribution	9999-12-31
Primary	06938327909512	GS1
Package	26938327909516	GS1	carton	2	In Commercial Distribution	9999-12-31