ClickClean™ UL030

GUDID 04719872920113

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.

MEDEON BIODESIGN, INC.

Endoscope lens cleaner, gas/fluid, single-use

• Primary Device ID: 04719872920113
• NIH Device Record Key: 5004142e-cc96-41e5-a7d0-47de9c89fe2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClickClean™
• Version Model Number: UL030
• Catalog Number: UL030
• Company DUNS: 656078460
• Company Name: MEDEON BIODESIGN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872920090 [Primary]
GS1	04719872920106 [Package]; Contains: 04719872920090; Package: Box [1 Units]; In Commercial Distribution
GS1	04719872920113 [Package]; Contains: 04719872920106; Package: Carton [12 Units]; In Commercial Distribution

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2018-11-20

On-Brand Devices [ClickClean™ ]

• 04719872920144: The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device cons
• 04719872920113: The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device cons
• 04719872920045: The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device cons
• 04719872920120: The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device cons
• 04719872920090: The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device cons
• 04719872920250: The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device cons
• 04719872920281: The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device cons