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 ID00865309000256
NIH Device Record Key78de0e40-c404-4056-bc0b-34abe88c78b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiLumen Ig Interventional Grasper
Version Model NumberDiLumen Ig 140 cm
Catalog NumberD-3001
Company DUNS859290897
Company NameLUMENDI LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8444810822
Emailinfo@lumendi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100865309000256 [Primary]

FDA Product Code

PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-21
Device Publish Date2018-12-14

On-Brand Devices [DiLumen Ig Interventional Grasper]

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

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