Home GUDID 05391533810064 ProVee System for BPH
Primary DI 05391533810064
Brand ProVee System for BPH
Company PROVERUM LIMITED
Model PV-002
Catalog number PV-002
Published 2025-12-15
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MER Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MER Stent, Urethral, Prostatic, Permanent Or Semi-Permanent Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391533810064 Package GS1 1 In Commercial Distribution 05391533810071 Package GS1 5 In Commercial Distribution 05391533810057 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391533810064 05391533810064 5391533810064 05391533810071 05391533810071 5391533810071 05391533810057 05391533810057 5391533810057
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Degrees Celsius 90 Degrees Celsius Storage Environment Temperature -30 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 985653597 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05391533810057 ProVee System for BPH PV-002 PV-002 2025-12-15 05391533810088 ProVee Video Processing Unit PV-003 2025-12-02 05391533810095 ProVee Video Processing Unit PV-003 2025-12-02
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850081334002 Zenflow Spring® Implant and Delivery System ZENFLOW, INC. MER 2026-05-22 00850081334019 Zenflow Spring® Implant and Delivery System ZENFLOW, INC. MER 2026-05-22 00850081334026 Zenflow Spring® Implant and Delivery System ZENFLOW, INC. MER 2026-05-22 05391533810057 ProVee System for BPH PROVERUM LIMITED MER 2025-12-15
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