DiLumen Is Endolumenal Interventional Scissors D-3101

GUDID 00865309000263

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

LUMENDI LLC

Flexible endoscopic scissors, single-use

• Primary Device ID: 00865309000263
• NIH Device Record Key: 37c0aec4-89ae-469e-a0f6-f5f8de763396
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiLumen Is Endolumenal Interventional Scissors
• Version Model Number: DiLumen Is 140 cm
• Catalog Number: D-3101
• Company DUNS: 859290897
• Company Name: LUMENDI LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8444810822
• Email: info@lumendi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865309000263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173405

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-14
• Device Publish Date: 2018-12-14

On-Brand Devices [DiLumen Is Endolumenal Interventional Scissors]

• 00865309000270: The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol
• 00865309000263: The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol