Zenflow Spring® Implant and Delivery System
- Primary DI
- 00850081334002
- Brand
- Zenflow Spring® Implant and Delivery System
- Company
- ZENFLOW, INC.
- Model
- ZFS-IMP-15-01
- Catalog number
- ZFS-IMP-15-01
- 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 |
|---|
| MER | Stent, Urethral, Prostatic, Permanent Or Semi-Permanent |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MER | Stent, Urethral, Prostatic, Permanent Or Semi-Permanent | Unknown | 3 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| P250007 | 000 | Zenflow Spring® Implant and Delivery System | Zenflow, Inc. | 2025-12-11 | MER |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850081334002 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850081334002 | 00850081334002 | 850081334002 | 0850081334002 |
GMDN Terms
| 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 |
|---|
| 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 | Catalog | Published |
|---|
| 00850081334019 | Zenflow Spring® Implant and Delivery System | ZFS-IMP-18-01 | ZFS-IMP-18-01 | 2026-05-22 |
| 00850081334026 | Zenflow Spring® Implant and Delivery System | ZFS-IMP-21-01 | ZFS-IMP-21-01 | 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 | Product code | Published |
|---|
| 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 |
| 05391533810064 | ProVee System for BPH | PROVERUM LIMITED | MER | 2025-12-15 |
zenflow.com