FDA.reportPublic FDA data

DiLumen Is Endolumenal Interventional Scissors

Primary DI
00865309000263
Brand
DiLumen Is Endolumenal Interventional Scissors
Company
LUMENDI LLC
Model
DiLumen Is 140 cm
Catalog number
D-3101
Device description
The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
Published
2018-12-14
Public version status
New
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173405000DiLumen Endolumenal Interventional Scissors (DiLumen Is)Lumendi, LLC2018-05-22GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865309000263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865309000263008653090002638653090002630865309000263

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic scissors, single-useA flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. 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
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
00865309000256DiLumen Ig Interventional GrasperDiLumen Ig 140 cmD-30012018-12-14
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

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B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
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