FDA.reportPublic FDA data

DiLumen Ig Interventional Grasper

Primary DI
00865309000256
Brand
DiLumen Ig Interventional Grasper
Company
LUMENDI LLC
Model
DiLumen Ig 140 cm
Catalog number
D-3001
Device 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.
Published
2018-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865309000256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865309000256008653090002568653090002560865309000256

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8444810822info@lumendi.com

Regulatory Flags#

DUNS number
859290897
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858836007164DiLumen C1, 130 cmDiLumen C1, 130 cmD-21002023-05-01
00858836007171DiLumen EZ1, 130 cmDiLumen EZ1, 130 cmD-11002023-05-01
00858836007188DiLumen C1, 103 cmDiLumen C1, 103 cmD-21012023-05-01
00858836007195DiLumen EZ1, 103 cmDiLumen EZ1, 103 cmD-11012023-05-01
00858836007102DiLumen Interventional GrasperIgE 125cmD-30102020-08-25
00858836007041DiLumen Ik Endolumenal Interventional KnifeDiLumen Ik 95 cmD-32002019-12-26
00858836007058DiLumen Ik Endolumenal Interventional KnifeDiLumen Ik 140 cmD-32012019-12-26
00858836007065DiLumen C2DiLumen C2.2 130 cmD-20042019-12-26
00858836007089DiLumen C2DiLumen C2.2 103 cmD-20052019-12-26
00865309000287DiLumen Ig Interventional GrasperDiLumen Ig 95 cmD-30002018-12-14
00858836007003DiLumen Im Interventional Tool MountDiLumen ImD-40002018-12-19
00865309000232DiLumen Endolumenal Interventional Platform, 103 cmDiLumen, 103 cmD-10022018-12-19
00865309000225DiLumen Endolumenal Interventional Platform, 130 cmDiLumen, 130 cmD-10012018-12-19
10865309000239DiLumen Endolumenal Interventional Platform, 103 cmDiLumen, 103 cmD-10022018-12-19
00858836007027DiLumen C2DiLumen C2 130 cmD-20012018-12-14
00858836007034DiLumen C2DiLumen C2 103 cmD-20022018-12-14
00865309000249DiLumen C2DiLumen C2 168 cmD-20002018-12-14
10858836007024DiLumen C2DiLumen C2 130 cmD-20012018-12-14
10858836007031DiLumen C2DiLumen C2 103 cmD-20022018-12-14
10865309000246DiLumen C2DiLumen C2 168 cmD-20002018-12-14

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