INT

Basic Information

• Brand Name: INT
• Primary DI: 06950900929403
• Version / Model: YCK111C
• Company Name: Shanghai Kindly Medical Instruments Co., Ltd.
• Labeler DUNS: 420827639
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-14
• Public Version: 1
• Public Version Date: 2023-08-22
• Public Version Status: New
• Public Device Record Key: e048224a-8a65-4907-8a36-4a93795b1db8

Device Description

Screw type Y connector,torque device(copper core), insertion tool;

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	870.4290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65480	Vascular guidewire introduction sleeve	A noninvasive tubular device designed to be connected to the proximal (external) end of an in situ vascular introducer or guide catheter, and inserted beyond the pre-opened haemostatic valve, to facilitate introduction of a vascular guidewire. It is intended to channel the guidewire to prevent bending/kinking as forward pressure is applied. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16950900929400	GS1	box	25	In Commercial Distribution
Primary	06950900929403	GS1
Package	56950900929408	GS1	carton	100	In Commercial Distribution
Package	26950900929407	GS1	box	50	In Commercial Distribution
Package	46950900929401	GS1	carton	200	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K170024	000