Anrei

Basic Information

• Brand Name: Anrei
• Primary DI: 06926839809130
• Version / Model: NE-C2536
• Company Name: Anrei Medical(HZ) Co.,Ltd.
• Labeler DUNS: 529128653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-07
• Public Version: 1
• Public Version Date: 2025-01-15
• Public Version Status: New
• Public Device Record Key: 02f8093d-d294-49d7-ac03-7897f1472ab1

Device Description

Single Use Injection Needle

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: No
• 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
64114	Sclerotherapy endoscopic needle, single-use	A device intended to be used with an appropriate endoscope to inject a pharmaceutical into mucosa or a vessel during sclerotherapy (a treatment that involves injecting varicose veins with a sclerosing fluid). It is in the form of a flexible tube with a needle at the distal end and a syringe connector at the proximal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06926839809130	GS1

Premarket Submissions

Submission Number	Supplement Number
K210917	000