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DiLumen Ig Interventional Grasper

FDA UDI

Class II (US FDA UDI)

by Lumendi Llc

Identity

Trade Name
DiLumen Ig Interventional Grasper FDA UDI
Generic Name
Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
DiLumen Ig 95 cm FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
D-3000 FDA UDI
Primary DI / UDI-DI
00865309000287 FDA UDI
FDA Product Code
PTS FDA UDI
GMDN Term
Flexible endoscopic tissue manipulation forceps, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Flexible endoscopic tissue manipulation forceps, single-use

DiLumen Ig Interventional Grasper by Lumendi Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible endoscopic tissue manipulation forceps, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lumendi Llc

Sources (1)

  • FDA UDI e26ab333-0abf-4c72-bbbd-7edcd82bc1cc 35 fields · synced Jun 1, 2026