ProVee System for BPH

Basic Information

• Brand Name: ProVee System for BPH
• Primary DI: 05391533810057
• Version / Model: PV-002
• Catalog Number: PV-002
• Company Name: PROVERUM LIMITED
• Labeler DUNS: 985653597
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-15
• Public Version: 2
• Public Version Date: 2026-04-02
• Public Version Status: Update
• Public Device Record Key: 03c17a98-e0bc-4d68-b966-b0346e115c69

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MER	Stent, Urethral, Prostatic, Permanent Or Semi-Permanent	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
42716	Bare-metal urethral stent, long-term	A non-bioabsorbable tubular or ring-like device intended to be implanted indefinitely/long-term in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve obstructions from bulbar urethral strictures, benign prostatic hyperplasia (BPH), and/or detrusor external sphincter dyssynergia (DESD). It is made entirely of metal (e.g., Nitinol) and may be meshed to facilitate embedding in the surrounding tissue. It may be inserted with a balloon catheter or may self-expand in situ; disposable devices (non-powered or electronic) dedicated to implantation may be included with the stent.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391533810064	GS1	Cardboard Box	1	In Commercial Distribution
Primary	05391533810057	GS1
Package	05391533810071	GS1	Cardboard Box	5	In Commercial Distribution
Package	05391533810125	GS1	Cardboard Box	4	In Commercial Distribution
Package	05391533810132	GS1	Cardboard Box	3	In Commercial Distribution
Package	05391533810149	GS1	Cardboard Box	2	In Commercial Distribution
Package	05391533810156	GS1	Cardboard Box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P250011	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Degrees Celsius