DiLumen Ig Interventional Grasper D-3001

GUDID 00865309000256

The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, single use, disposable device intended to be used for grasping and manipulating tissue within the digestive tract under direct endoscopic visualization. The DiLumen Ig utilizes a pistol style handle, flexible 5mm shaft with an articulating section at the distal end and jaws that have DeBakey pattern teeth to allow one-handed operation for secure grasping and manipulation of tissue during endoscopic procedures. The DiLumen Ig handle incorporates controls that allow the user to rotate the shaft in a specific plane, rotate the jaws 360º, articulate the distal end of the shaft, open and close the jaws, and lock the articulation in a fixed position.

LUMENDI LLC

Flexible endoscopic tissue manipulation forceps, single-use

• Primary Device ID: 00865309000256
• NIH Device Record Key: 78de0e40-c404-4056-bc0b-34abe88c78b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiLumen Ig Interventional Grasper
• Version Model Number: DiLumen Ig 140 cm
• Catalog Number: D-3001
• Company DUNS: 859290897
• Company Name: LUMENDI LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00865309000256 [Primary]

FDA Product Code

• PTS: Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

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: 2019-08-21
• Device Publish Date: 2018-12-14

On-Brand Devices [DiLumen Ig Interventional Grasper]

• 00865309000287: The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, single use, disp
• 00865309000256: The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, single use, disp