← Back to catalogue
DiLumen Im Interventional Tool Mount
FDA UDIClass I (US FDA UDI)
by Lumendi Llc
Identity
- Trade Name
- DiLumen Im Interventional Tool Mount FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- DiLumen Im FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- D-4000 FDA UDI
- Primary DI / UDI-DI
- 00858836007003 FDA UDI
- 510(k) Number
- K173317 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
DiLumen Im Interventional Tool Mount by Lumendi Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument assist arm system, manually-adjusted.
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · Class I
- Scope cable holder — Olympus Medical Systems Corporation · Class II
- Smeed Technologies — SMEED TECHNOLOGIES LLC · Class I
- Flexarm Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
- Flexarm Plus Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
- Flexarm Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · Class I
- ASSISTO® Arm-System — Geomed Medizin-Technik GmbH & Co. KG · Class II
Cleared under the same submission
K173317 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lumendi Llc
Sources (1)
- FDA UDI 6a845b33-fbe3-436e-8718-ac3f2e9dac46 36 fields · synced Jun 8, 2026