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 ID: 00858836007003
• NIH Device Record Key: 6a845b33-fbe3-436e-8718-ac3f2e9dac46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiLumen Im Interventional Tool Mount
• Version Model Number: DiLumen Im
• Catalog Number: D-4000
• Company DUNS: 859290897
• Company Name: LUMENDI LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8444810822
• Email: info@lumendi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858836007003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173317

FDA Product Code

• FWZ: Operating Room Accessories Table Tray

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00858836007003]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-11
• Device Publish Date: 2018-12-19

Devices Manufactured by LUMENDI LLC

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• 00858836007171 - DiLumen EZ1, 130 cm: 2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine
• 00858836007188 - DiLumen C1, 103 cm: 2023-05-09 The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine,
• 00858836007195 - DiLumen EZ1, 103 cm: 2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine
• 00858836007102 - DiLumen Interventional Grasper: 2020-09-02 125 cm flexible shaft grasper with elbow bending section and articulating distal tip
• 00858836007041 - DiLumen Ik Endolumenal Interventional Knife: 2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend
• 00858836007058 - DiLumen Ik Endolumenal Interventional Knife: 2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend
• 00858836007065 - DiLumen C2: 2020-01-03 DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind th