DiLumen Ik Endolumenal Interventional Knife D-3201

GUDID 00858836007058

The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. The device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization. The DiLumen Ik utilizes a pistol style Handle, a Flexible Shaft with an articulating section at its distal end, and a stainless-steel Knife Tip that can be extended and retracted. The Handle incorporates controls that allow the clinician to rotate the Shaft, extend or retract the Knife Tip, articulate the distal end of the Shaft in a specific plane, and lock the articulation in a fixed position. There is also a female Luer Lock connector on the Handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing tissue debris from the knife tip or creating a bleb to lift mucosal lesions

LUMENDI LLC

Endoscopic electrosurgical submucosal lift/resection set

• Primary Device ID: 00858836007058
• NIH Device Record Key: b2f00d43-2f0b-4959-9fd5-1c5bd39e4747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiLumen Ik Endolumenal Interventional Knife
• Version Model Number: DiLumen Ik 140 cm
• Catalog Number: D-3201
• 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	00858836007058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183112

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-12-26

On-Brand Devices [DiLumen Ik Endolumenal Interventional Knife]

• 00858836007058: The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopol
• 00858836007041: The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopol