Home GUDID 00850081334026 Zenflow Spring® Implant and Delivery System
Primary DI 00850081334026
Brand Zenflow Spring® Implant and Delivery System
Company ZENFLOW, INC.
Model ZFS-IMP-21-01
Catalog number ZFS-IMP-21-01
Published 2026-05-22
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 00850081334026 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850081334026 00850081334026 850081334026 0850081334026
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.
Device Sizes# Type, Value, Unit table Type Value Unit Stent Length 0
Regulatory Flags# DUNS number 079412969 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true 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 00850081334002 Zenflow Spring® Implant and Delivery System ZFS-IMP-15-01 ZFS-IMP-15-01 2026-05-22 00850081334019 Zenflow Spring® Implant and Delivery System ZFS-IMP-18-01 ZFS-IMP-18-01 2026-05-22 00850081334033 Zenflow Spring® Scope ZFS-SCP-01 ZFS-SCP-01 2026-05-22 00850081334040 Zenflow Spring® Implant Retrieval Device ZFS-IRD-01 ZFS-IRD-01 2026-05-22 00850081334057 Zenflow Camera Control Unit ZFS-CCU-01 ZFS-CCU-01 2026-05-22
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 05391533810057 ProVee System for BPH PROVERUM LIMITED MER 2025-12-15 05391533810064 ProVee System for BPH PROVERUM LIMITED MER 2025-12-15
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