ProVee System for BPH PV-002

GUDID 05391533810064

PROVERUM LIMITED

Bare-metal urethral stent, long-term

• Primary Device ID: 05391533810064
• NIH Device Record Key: 03c17a98-e0bc-4d68-b966-b0346e115c69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProVee System for BPH
• Version Model Number: PV-002
• Catalog Number: PV-002
• Company DUNS: 985653597
• Company Name: PROVERUM LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +18136947149
• Email: orders@proverummedical.com
• Phone: +18136947149
• Email: orders@proverummedical.com
• Phone: +18136947149
• Email: orders@proverummedical.com
• Phone: +18136947149
• Email: orders@proverummedical.com
• Phone: +18136947149
• Email: orders@proverummedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Degrees Celsius and 90 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Degrees Celsius and 90 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Degrees Celsius and 90 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Degrees Celsius and 90 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Degrees Celsius and 90 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391533810057 [Primary]
GS1	05391533810064 [Package]; Contains: 05391533810057; Package: Cardboard Box [1 Units]; In Commercial Distribution
GS1	05391533810071 [Package]; Package: Cardboard Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P250011

FDA Product Code

• MER: Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

Devices Manufactured by PROVERUM LIMITED

• 05391533810064 - ProVee System for BPH: 2025-12-23
• 05391533810064 - ProVee System for BPH: 2025-12-23
• 05391533810095 - ProVee Video Processing Unit: 2025-12-10