DiLumen Im Interventional Tool Mount D-4000

GUDID 00858836007003

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.

LUMENDI LLC

Surgical instrument assist arm system, manually-adjusted
Primary Device ID00858836007003
NIH Device Record Key6a845b33-fbe3-436e-8718-ac3f2e9dac46
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiLumen Im Interventional Tool Mount
Version Model NumberDiLumen Im
Catalog NumberD-4000
Company DUNS859290897
Company NameLUMENDI LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8444810822
Emailinfo@lumendi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858836007003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FWZOperating Room Accessories Table Tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858836007003]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-11
Device Publish Date2018-12-19

Devices Manufactured by LUMENDI LLC

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00858836007171 - DiLumen EZ1, 130 cm2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine
00858836007188 - DiLumen C1, 103 cm2023-05-09 The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine,
00858836007195 - DiLumen EZ1, 103 cm2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine
00858836007102 - DiLumen Interventional Grasper2020-09-02 125 cm flexible shaft grasper with elbow bending section and articulating distal tip
00858836007041 - DiLumen Ik Endolumenal Interventional Knife2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend
00858836007058 - DiLumen Ik Endolumenal Interventional Knife2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend
00858836007065 - DiLumen C22020-01-03 DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind th

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