WiScope®

GUDID 10850023925432

Single-Use Digital Flexible Cystoscope

Otu Medical Inc.

Flexible video cystoscope, single-use

• Primary Device ID: 10850023925432
• NIH Device Record Key: 227230a9-bf43-425b-91fd-a33abb5ba41f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiScope®
• Version Model Number: OTU-C311R
• 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: 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	00850023925435 [Primary]
GS1	10850023925432 [Package]; Contains: 00850023925435; Package: [2 Units]; In Commercial Distribution
GS1	20850023925439 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212202

FDA Product Code

• FAJ: Cystoscope 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: 2024-10-08
• Device Publish Date: 2024-09-30

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