Neoscope

GUDID 00851545007623

NEOFLEX-FLEXIBLE VIDEO URETEROSCOPE

PROSURG INC

Flexible video ureteroscope, reusable

• Primary Device ID: 00851545007623
• NIH Device Record Key: 8b172aec-da34-40d3-a35c-fe5521f1d90d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neoscope
• Version Model Number: NFU 9
• Company DUNS: 188684609
• Company Name: PROSURG 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

Customer Support Contacts

• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net

Device Dimensions

• Catheter Gauge: 9 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851545007623 [Primary]
GS1	10851545007620 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120766

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-22
• Device Publish Date: 2016-09-23

On-Brand Devices [Neoscope]

• 00851545007623: NEOFLEX-FLEXIBLE VIDEO URETEROSCOPE
• 00851545007487: NEO- HYSTEROSCOPE OPERATING SHEATH
• 00851545007470: NEO-CYSTOSCOPE , DIAGNOSTIC SHEATH
• 00851545007463: NEO-CYSTOSCOPE , DIGITAL VIDEOSCOPE
• 00851545007579: NEOFLEX - FLEXIBLE VIDEO BRONCHOSCOPE
• 00851545007562: NEOFLEX- FLEXIBLE VIDEO BRONCHOSCOPE
• 00851545007531: NEO -CYSTOSCOPE, OPERATING SHEATH
• 00851545007524: NEOFLEX-FLEXIBLE VIDEO HYSTEROSCOPE
• 00851545007494: NEO- HYSTEROSCOPE, DIGITAL VIDEOSCOPE
• 00851545007548: NEOFLEX -FLEXIBLE VIDEO CYSTOSCOPE
• 00851545007500: NEO-HYSTEROSCOPE DIAGNOSTIC SHEATH