WiScope® 4201A0501W

GUDID 06972084140399

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

Ningbo Wise Optomech Technology Corporation

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 06972084140399
• NIH Device Record Key: e162b8a1-f89c-4c45-bfd5-05291407009b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiScope®
• Version Model Number: OTU-A
• Catalog Number: 4201A0501W
• 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	06972084140399 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-13
• Device Publish Date: 2023-04-05

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