Signature Series

GUDID 08714729520368

Electrosurgical Devices, Roller Ball

PROSURG INC

Electrosurgical system

• Primary Device ID: 08714729520368
• NIH Device Record Key: 25cc2cad-8467-404c-aaec-1e70c27dcad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature Series
• Version Model Number: M0068802060
• 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
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net

Device Dimensions

• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French
• Catheter Gauge: 27 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729160458 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	08714729520368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962593

FDA Product Code

• FAS: Electrode, Electrosurgical, Active, Urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-04
• Device Publish Date: 2016-09-23

On-Brand Devices [Signature Series ]

• 08714729775164: Electrosurgical Devices, Incision Blade
• 08714729775171: Electrosurgical Devices, TUIP Knife
• 08714729813644: Electrosurgical Devices, Power Ball
• 08714729775140: Electrosurgical Devices, Roller Ball
• 08714729773849: Electrosurgical Devices, Roller Ball OLYMPUS OES PRO 3.0mm ROLLER BALL 24FR
• 08714729813637: Electrosurgical Devices, Cutting Loop
• 08714729775157: Electrosurgical Devices, Cutting Loop
• 08714729773672: Electrosurgical Devices, Cutting Loop
• 08714729890157: Electrosurgical Devices, Cutting Loop
• 08714729516729: Electrosurgical Devices, Cutting Loop
• 08714729890126: Electrosurgical Devices, cutting Loop
• 08714729820611: Electrosurgical Devices, Resection Loop
• 08714729813613: Electrosurgical Devices, Resection Loop
• 08714729820048: Electrosurgical Devices, Resection Loop
• 08714729813620: Electrosurgical Devices, Resection Loop
• 08714729802723: Electrosurgical Devices, Resection Loop
• 08714729520658: Electrosurgical Devices, Incision Blade
• 08714729520641: Electrosurgical Devices, Incision Blade
• 08714729516712: Electrosurgical Devices, Cutting Loop
• 08714729875574: Electrosurgical Devices, Power Ball
• 08714729875567: Electrosurgical Devices, Cutting Loop
• 08714729258391: Electrosurgical Devices, Incision Blade
• 08714729258384: I Electrosurgical Devices, Incision Blade
• 08714729258377: Electrosurgical Devices, Incision Blade
• 08714729258360: Electrosurgical Devices, Incision Blade
• 08714729753421: Electrosurgical Devices, cutting Loop
• 08714729753414: Electrosurgical Devices, Cutting Loop
• 08714729753407: Electrosurgical Devices, Power Ball
• 08714729753391: Electrosurgical Devices, Cutting Loop
• 08714729753384: Electrosurgical Devices, Cutting Loop
• 08714729753377: Electrosurgical Devices, power Ball OLYMPUS POWERBALL 24 FR
• 08714729753360: Electrosurgical Devices, Cutting Loop
• 08714729753353: Electrosurgical Devices, Cutting Loop
• 08714729753346: Electrosurgical Devices, Power Ball
• 08714729753339: Electrosurgical Devices, Cutting Loop
• 08714729753322: Electrosurgical Devices, Cutting Loop
• 08714729753315: Electrosurgical Devices, Power Ball
• 08714729753308: Electrosurgical Devices, Cutting Loop
• 08714729753292: Electrosurgical Devices, Cutting Loop
• 08714729160410: Electrosurgical Devices, Power Ball
• 08714729516811: Electrosurgical Devices, Roller Ball
• 08714729516804: Electrosurgical Devices, Roller Ball
• 08714729258353: Electrosurgical Devices, Roller Ball
• 08714729258346: Electrosurgical Devices, Roller ball
• 08714729258339: Electrosurgical Devices, Roller Ball
• 08714729258322: Electrosurgical Devices, Roller Ball
• 08714729258315: Electrosurgical Devices, Roller Ball
• 08714729258308: Electrosurgical Devices, Roller Ball
• 08714729516798: Electrosurgical Devices, Roller ball
• 08714729516781: Electrosurgical Devices, Roller Ball