VS3 Iridium 153-0053RFB

GUDID 10813040013254

VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View - Refurbished

VISIONSENSE LTD.

Endoscope video camera

• Primary Device ID: 10813040013254
• NIH Device Record Key: de14260d-ada9-4c7a-b43d-498d56e90654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Iridium
• Version Model Number: VS3-IR
• Catalog Number: 153-0053RFB
• 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	10813040013254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183453

FDA Product Code

• HRX: Arthroscope

Sterilization

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

[10813040013254]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-15
• Device Publish Date: 2020-04-07

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