Pack of 10 Drapes for VS3 Iridium Fluorescence (MMS-IR) 115-0012

GUDID 18130400103533

VISIONSENSE LTD.

Endoscope video camera

• Primary Device ID: 18130400103533
• NIH Device Record Key: c8a0b2d1-374f-42e6-9988-0de1298de306
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pack of 10 Drapes for VS3 Iridium Fluorescence (MMS-IR)
• Version Model Number: VS3-IR
• Catalog Number: 115-0012
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18130400103533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183453

FDA Product Code

• HRX: Arthroscope
• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-13
• Device Publish Date: 2019-12-01

On-Brand Devices [Pack of 10 Drapes for VS3 Iridium Fluorescence (MMS-IR) ]

• 18130400103533: VS3-IR
• 10813040013681: VS3-IR