WiScope®

GUDID 16972084140037

Single-Use Digital Flexible Ureteroscope

Ningbo Wise Optomech Technology Corporation

Flexible video ureteroscope, reusable

• Primary Device ID: 16972084140037
• NIH Device Record Key: edb59521-77be-4684-b92c-40b5ff74140a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiScope®
• Version Model Number: OTU-100SL
• 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: 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	06972084140030 [Primary]
GS1	16972084140037 [Package]; Contains: 06972084140030; Package: [10 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-11
• Device Publish Date: 2019-01-10

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