FDA.reportPublic FDA data

DiLumen Im Interventional Tool Mount

Primary DI
00858836007003
Brand
DiLumen Im Interventional Tool Mount
Company
LUMENDI LLC
Model
DiLumen Im
Catalog number
D-4000
Device description
"The DiLumen Interventional Tool Mount (""DiLumen Im"") is a dedicated accessory for the DiLumen C2 that facilitates use of the DiLumen C2 tool channels by holding these channels in a fixed position. The Tool Mount consists of the FISSO Holding System with an added, permanently attached stainless steel tool bar to firmly hold the DiLumen C2 tool channels in the clinician’s preferred orientation. The Tool Mount and holding system is attached to a standard surgical table rail using a rail clamp."
Published
2018-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173317000DiLumen C2; DiLumen Tool MountLumendi, LLC2018-04-17FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858836007003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858836007003008588360070038588360070030858836007003

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8444810822info@lumendi.com

Regulatory Flags#

DUNS number
859290897
Device count
1
Serial number
true
Sterilization required before use
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
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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