DiLumen Im Interventional Tool Mount

Basic Information

• Brand Name: DiLumen Im Interventional Tool Mount
• Primary DI: 00858836007003
• Version / Model: DiLumen Im
• Catalog Number: D-4000
• Company Name: LUMENDI LLC
• Labeler DUNS: 859290897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-19
• Public Version: 2
• Public Version Date: 2019-03-11
• Public Version Status: Update
• Public Device Record Key: 6a845b33-fbe3-436e-8718-ac3f2e9dac46

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62379	Surgical instrument assist arm system, manually-adjusted	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858836007003	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173317	000