DiLumen Is Endolumenal Interventional Scissors

Basic Information

• Brand Name: DiLumen Is Endolumenal Interventional Scissors
• Primary DI: 00865309000263
• Version / Model: DiLumen Is 140 cm
• Catalog Number: D-3101
• Company Name: LUMENDI LLC
• Labeler DUNS: 859290897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-14
• Public Version: 1
• Public Version Date: 2019-01-14
• Public Version Status: New
• Public Device Record Key: 37c0aec4-89ae-469e-a0f6-f5f8de763396

Device Description

The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically

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: 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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46420	Flexible endoscopic scissors, single-use	A flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865309000263	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173405	000