ProVee System for BPH

Primary DI
05391533810057
Brand
ProVee System for BPH
Company
PROVERUM LIMITED
Model
PV-002
Catalog number
PV-002
Published
2025-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MERStent, Urethral, Prostatic, Permanent Or Semi-Permanent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MERStent, Urethral, Prostatic, Permanent Or Semi-PermanentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250011000ProVee System for BPHProverum, Ltd.2025-12-09MER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391533810064PackageGS11In Commercial Distribution
05391533810071PackageGS15In Commercial Distribution
05391533810125PackageGS14In Commercial Distribution
05391533810132PackageGS13In Commercial Distribution
05391533810149PackageGS12In Commercial Distribution
05391533810156PackageGS11In Commercial Distribution
05391533810057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391533810064053915338100645391533810064
05391533810071053915338100715391533810071
05391533810125053915338101255391533810125
05391533810132053915338101325391533810132
05391533810149053915338101495391533810149
05391533810156053915338101565391533810156
05391533810057053915338100575391533810057

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal urethral stent, long-termA 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
TypeLowHighCondition
Storage Environment Humidity10 Degrees Celsius90 Degrees Celsius
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+16124845300orders@proverummedical.com

Regulatory Flags#

DUNS number
985653597
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391533810064ProVee System for BPHPV-002PV-0022025-12-15
05391533810088ProVee Video Processing UnitPV-0032025-12-02
05391533810095ProVee Video Processing UnitPV-0032025-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850081334002Zenflow Spring® Implant and Delivery SystemZENFLOW, INC.MER2026-05-22
00850081334019Zenflow Spring® Implant and Delivery SystemZENFLOW, INC.MER2026-05-22
00850081334026Zenflow Spring® Implant and Delivery SystemZENFLOW, INC.MER2026-05-22
05391533810064ProVee System for BPHPROVERUM LIMITEDMER2025-12-15