Prostiva Hand Piece

GUDID M87689290

Prostiva RF Therapy Hand Piece

Urologix LLC

Rigid cystoscope

• Primary Device ID: M87689290
• NIH Device Record Key: 606b15c2-08ef-45fe-9576-3f209940c272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prostiva Hand Piece
• Version Model Number: 8929
• Company DUNS: 785735796
• Company Name: Urologix LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com
• Phone: 888.475.0772
• Email: customerservice@urologix.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M87689290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113380

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2022-06-10
• Device Publish Date: 2016-09-22