Prosurg RF Electrodes

GUDID 00851545007081

CUTTING LOOP STORZ

PROSURG INC

Electrosurgical system

• Primary Device ID: 00851545007081
• NIH Device Record Key: a7ee091a-cdaf-40df-8899-e45e6a064f7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosurg RF Electrodes
• Version Model Number: CL 27 S
• 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: 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
• Catheter Gauge: 27 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851545007081 [Primary]
GS1	10851545007088 [Package]; Package: Box [10 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: 2020-04-24
• Device Publish Date: 2016-09-23

On-Brand Devices [Prosurg RF Electrodes]

• 00851545007296: TUIP KNIFE WOLF
• 00851545007258: TUIP KNIFE STORZ
• 00851545007234: INCISION BLADE 24 CIRCON
• 00851545007227: INCISION BLADE STORZ
• 00851545007210: ROLLER BALL 5.0mm OLYMPUS (OES)
• 00851545007166: SINGLE BAR OLYMPUS ( OES PRO)
• 00851545007159: SINGLE BAR OLYMPUS (OES)
• 00851545007142: SINGLE BAR CIRCON
• 00851545007135: SINGLE BAR STORZ
• 00851545007128: ROLLER BALL WOLF
• 00851545007098: ROLLER BALL 3.0mm STORZ
• 00851545007074: CUTTING LOOP CIRCON
• 00851545007050: CUTTING LOOP OLYMPUS (OES PRO)
• 00851545007272: TUIP KNIFE OLYMPUS (OES)
• 00851545007265: TUIP KNIFE CIRCON
• 00851545007241: INCISION BLADE OLYMPUS (OES)
• 00851545007203: ROLLER BALL 5.0mm CIRCON
• 00851545007197: ROLLER BALL 5.0mm STORZ (SINGLE)
• 00851545007111: ROLLER BALL 3.0mm OLYMPUS (OES)
• 00851545007104: ROLLER BALL 3.0mm CIRCON
• 00851545007067: CUTTING LOOP WOLF
• 00851545007043: CUTTING LOOP OLYMPUS (OES )
• 00851545007012: CUTTING LOOP STORZ (SINGLE)
• 00851545007173: SINGLE BAR WOLF
• 00851545007081: CUTTING LOOP STORZ