Prosurg NCO18

GUDID 10851545007590

Neo-Cystoscope 6.0mm Rigid with /Dueal channel 5.0 & 8.0

PROSURG INC

Flexible video cystoscope, single-use

• Primary Device ID: 10851545007590
• NIH Device Record Key: a783269c-6344-4b14-afb6-c4c65b6de0e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosurg
• Version Model Number: NCO18
• Catalog Number: NCO18
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 408-483-5474
• Email: Ashvin@prosurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851545007593 [Primary]
GS1	10851545007590 [Package]; Contains: 00851545007593; Package: Inner Pak [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: true
• Device Is Sterile: true

[10851545007590]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [Prosurg]

• 10851545007736: Neoflex Cystoscope 15FR
• 10851545007699: Neoscope Video Processing Link Module
• 10851545007682: Video Processing Module
• 10851545007675: Neo-Nephroscope Rigid W/50FR & 8.0 FR Operating Channel
• 10851545007668: Neo-Nephroscope Rigid W8.0 FR working Channel
• 10851545007651: Neo-Nephroscope 12 FR Rigid with 5.0 working channel
• 10851545007644: Neo-Nephroscope 9 FR Rigid With 3.6FR Channel
• 10851545007637: Neoscope 9FR Semi Rigid Ureter scope with 3.6 Channel
• 10851545007613: Neoflex Cystoscope 12 FR With .0 FR Channel
• 10851545007606: Neoscope Diagnostic Cystoscope
• 10851545007590: Neo-Cystoscope 6.0mm Rigid with /Dueal channel 5.0 & 8.0
• 10851545007583: Neo-Cystoscope 4.0 mm Rigid with 5.0 Fr Working Channel
• 10851545007828: Bladder Cutting Loop Electrode 24FR Storz Single Stem 15 Degrees
• 10851545007798: Salinetrode Bipolar Cable (Resuable)
• 10851545007743: Cutting Loop 24 FR Storz Double Stem
• 10851545007705: Salinetrode Bipolar Cable
• 10851545007439: Salinetrode 5.0 Fr 73 cm
• 10851545007422: Salinetrode Flex 5.0 Fr 40 cm
• 10851545007354: Salinetrode Cutting Loop 24 Wolf
• 10851545007330: Salinetrode Cutting Loop 24 FR
• 10851545007309: Salinetrode Cutting Loop 24 FR Double Stem
• 10851545007187: 5mm Roller Ball 24 Fr Storz Double Stem
• 10851545007811: Neo-Arthroscope 2.3 mm (15 Degrees)
• 10851545007729: Neo-Arthroscope 1.8 mm (0 Degrees)
• 10851545007712: Neo-Arthroscope 4.0 mm (30 Degrees)