Disposable Sclerotherapy Needle

Basic Information

• Brand Name: Disposable Sclerotherapy Needle
• Primary DI: 00813353010233
• Version / Model: 2010
• Company Name: Telemed Systems
• Labeler DUNS: 017939239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-24
• Public Version: 1
• Public Version Date: 2023-09-01
• Public Version Status: New
• Public Device Record Key: d4cfcdd6-f92a-47e2-a4a0-234c631d5a70

Device Description

Sure-Stop Sclerotherapy Needle 21GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length

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: Yes
• 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
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	00813353010233	GS1

Premarket Submissions

Submission Number	Supplement Number
K901437	000