Disposable Injection Needles

Basic Information

• Brand Name: Disposable Injection Needles
• Primary DI: 06942067959683
• Version / Model: XY-ZSZ-C-18×2300×23×6
• Company Name: Ningbo Xinwell Medical Technology Co., Ltd.
• Labeler DUNS: 544587864
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-05
• Public Version: 1
• Public Version Date: 2024-06-13
• Public Version Status: New
• Public Device Record Key: 875c3de6-d959-4be7-964e-35e3fb399bc6

Device Description

Disposable Injection Needles

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
45019	Submucosal injection needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16942067959680	GS1	BOX	10	In Commercial Distribution
Primary	06942067959683	GS1
Package	26942067959687	GS1	CASE	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K232200	000