WiScope®

GUDID 06972084140061

Image System, adapting to a monitor of 16:9 aspect ratio

Ningbo Wise Optomech Technology Corporation

Endoscopic video image processing unit

• Primary Device ID: 06972084140061
• NIH Device Record Key: cfbcc1de-fe9c-4805-bfea-038c966d7fcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiScope®
• Version Model Number: OTU-A
• Company DUNS: 540094524
• Company Name: Ningbo Wise Optomech Technology Corporation
• 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	06972084140061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181977

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

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: 2020-05-19
• Device Publish Date: 2019-08-22

On-Brand Devices [WiScope®]

• 06972084140054: Image System
• 16972084140044: Single-Use Digital Flexible Ureteroscope
• 16972084140037: Single-Use Digital Flexible Ureteroscope
• 16972084140020: Single-Use Digital Flexible Ureteroscope
• 06972084140016: Single-Use Digital Flexible Ureteroscope
• 16972084140105: Single-Use Digital Flexible UroScope
• 16972084140099: Single-Use Digital Flexible UroScope
• 06972084140085: Single-Use Digital Flexible UroScope
• 16972084140075: Single-Use Digital Flexible UroScope
• 06972084140061: Image System, adapting to a monitor of 16:9 aspect ratio
• 06972084140399: Image System, adapting to a monitor of 16:9 aspect ratio
• 06972084140412: Image System
• 06972084140405: Image System