Salinetrode Bipolar RF Electrode

GUDID 00851545007395

SALINETRODE DOME ELECTRODE OLYPMUS (OES PRO)

PROSURG INC

Electrosurgical system

• Primary Device ID: 00851545007395
• NIH Device Record Key: e5c41b75-885a-448e-8b5d-c80ea44363af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salinetrode Bipolar RF Electrode
• Version Model Number: SD 24 ON
• 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
• Phone: 408 945 4044
• Email: Prosurg_qa@sbcglobal.net

Device Dimensions

• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French
• Catheter Gauge: 24 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851545007395 [Primary]
GS1	10851545007392 [Package]; Package: Box [5 Units]; In Commercial Distribution

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: 2020-04-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Salinetrode Bipolar RF Electrode]

• 00851545007395: SALINETRODE DOME ELECTRODE OLYPMUS (OES PRO)
• 00851545007388: SALINETRODE DOME ELECTRODE WOLF
• 00851545007371: SALINETRODE DOME ELECTRODE CIRCON
• 00851545007326: SALINETRODE CUTTING LOOP OLYMPUS ( OES PRO )