Injection Needle

Basic Information

• Brand Name: Injection Needle
• Primary DI: 06970057576060
• Version / Model: VDK-IN-23-230-2506-A
• Company Name: Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
• Labeler DUNS: 544430136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-20
• Public Version: 2
• Public Version Date: 2024-08-29
• Public Version Status: Update
• Public Device Record Key: d620e165-504f-464d-8f08-9ef97795de52

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
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38825	General-purpose endoscopic needle, single-use	A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16970057576067	GS1	BOX	10	In Commercial Distribution
Primary	06970057576060	GS1
Package	56970057576065	GS1	carton	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K213914	000