Identity
- Trade Name
- ClickClean™ FDA UDI
- Generic Name
- Endoscope lens cleaner, gas/fluid, single-use FDA UDI
- Device Name
- The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids. FDA UDI
- Model / Reference
- UL330 FDA UDI
- Description
- The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids. FDA UDI
Identifiers
- Catalog Number
- UL330 FDA UDI
- Primary DI / UDI-DI
- 04719872920182 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscope lens cleaner, gas/fluid, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Endoscope lens cleaner, gas/fluid, single-use
ClickClean™ by Medeon Biodesign, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope lens cleaner, gas/fluid, single-use.
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- InstaClear — Gyrus Acmi, Inc. · Class II
- CS-05-30-300 OpClear Disposable — Cipher Surgical, Ltd. · Class II
- CS-10-00-330 OpClear Disposable — Cipher Surgical, Ltd. · Class II
- FloShield/Plus — Minimally Invasive Devices, LLC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medeon Biodesign, Inc.
Sources (1)
- FDA UDI e21cf661-9c6c-4117-9d4b-4ce32cef2986 34 fields · synced May 30, 2026