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Zenflow Spring® Implant and Delivery System ZFS-IMP-21-01

by Zenflow, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850081334026 UDI-DI Date22 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Zenflow Spring® Implant and Delivery System
Generic Name
Bare-metal urethral stent, long-term
Model / Ref / Catalog
ZFS-IMP-21-01
Primary DI / UDI-DI
00850081334026
PMA Number
FDA Product Code
MER
GMDN Term
Bare-metal urethral stent, long-term
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Stent Length — 21 Millimeter

Related devices

Cleared under the same submission (P250007)

Other devices from Zenflow, Inc.

See all devices from Zenflow, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No