WiScope® 4202T0101T

GUDID 00850023925312

Image System

Otu Medical Inc.

Endoscopic video image processing unit

• Primary Device ID: 00850023925312
• NIH Device Record Key: fb37f6f7-96ad-4c2c-a612-3db748b49bdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiScope®
• Version Model Number: OTU-T
• Catalog Number: 4202T0101T
• Company DUNS: 100796993
• Company Name: Otu Medical Inc.
• 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	00850023925312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231702

FDA Product Code

• FAJ: Cystoscope 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: 2024-01-22
• Device Publish Date: 2024-01-12

On-Brand Devices [WiScope®]

• 10850023925159: Single-Use Digital Flexible UroScope
• 00850023925145: Single-Use Digital Flexible Uroscope
• 00850023925138: Single-Use Digital Flexible UroScope
• 10850023925128: Single-Use Digital Flexible UroScope
• 00850023925114: Image System, adapting to a monitor of 16:9 aspect ratio.
• 00850023925107: Image System, adapting to a monitor of 16:9 aspect ratio.
• 00850023925091: Image System, adapting to a monitor of 4:3 aspect ratio.
• 00850023925084: Image System, adapting to a monitor of 4:3 aspect ratio.
• 10850023925074: Single-Use Digital Flexible Ureteroscope
• 10850023925067: Single-Use Digital Flexible Ureteroscope
• 10850023925050: Single-Use Digital Flexible Ureteroscope
• 10850023925043: Single-Use Digital Flexible Ureteroscope
• 10850023925197: Single-Use Digital Flexible Cystoscope
• 10850023925180: Single-Use Digital Flexible Cystoscope
• 10850023925173: Single-Use Digital Flexible Cystoscope
• 10850023925166: Single-Use Digital Flexible Cystoscope
• 00850023925282: Image System, adapting to a monitor of 16:9 aspect ratio
• 10850023925302: Single-Use Digital Flexible Ureteroscope/Choledochoscope
• 10850023925296: Single-Use Digital Flexible Ureteroscope/Choledochoscope
• 10850023925265: Single-Use Digital Flexible Ureteroscope/Choledochoscope
• 10850023925258: Single-Use Digital Flexible Ureteroscope/Choledochoscope
• 10850023925241: Single-Use Digital Flexible Ureteroscope/Choledochoscope
• 10850023925234: Single-Use Digital Flexible Ureteroscope/Choledochoscope
• 10850023925227: Single-Use Digital Flexible Bronchoscope
• 10850023925210: Single-Use Digital Flexible Bronchoscope
• 10850023925203: Single-Use Digital Flexible Bronchoscope
• 00850023925343: Image System
• 10850023925333: Single-Use Digital Flexible Ureteroscope
• 10850023925326: Single-Use Digital Flexible Ureteroscope
• 00850023925312: Image System
• 10850023925432: Single-Use Digital Flexible Cystoscope
• 10850023925425: Single-Use Digital Flexible Cystoscope