DiLumen Ig Interventional Grasper - The DiLumen Endolumenal Interventional Grasper - LUMENDI LLC

Duns Number:859290897

Device Description: The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, single use, di 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.

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More Product Details

Catalog Number

D-3001

Brand Name

DiLumen Ig Interventional Grasper

Version/Model Number

DiLumen Ig 140 cm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PTS

Product Code Name

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Device Record Status

Public Device Record Key

78de0e40-c404-4056-bc0b-34abe88c78b1

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

December 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUMENDI LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 11