VS3 Iridium 153-0073

GUDID 10813040013636

VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV

VISIONSENSE LTD.

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera

• Primary Device ID: 10813040013636
• NIH Device Record Key: 4f531e96-ffe9-402c-a8d3-16a9441fd7ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Iridium
• Version Model Number: VS3-IR
• Catalog Number: 153-0073
• Company DUNS: 532199478
• Company Name: VISIONSENSE LTD.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10813040013636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152204

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10813040013636]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-07-13
• Device Publish Date: 2019-08-07

On-Brand Devices [VS3 Iridium ]

• 10813040013261: VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV - Refurbished
• 10813040013254: VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View - Refurbished
• 10813040013858: VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View
• 10813040013636: VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV