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LumaFlex Double J stent, 2 open tips, Ch/Fr4, 8/L.30cm, without wire
FDA UDIClass II (US FDA UDI)
by Promepla
Identity
- Trade Name
- LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.30cm, without wire FDA UDI
- Generic Name
- Polymeric ureteral stent FDA UDI
- Model / Reference
- 09-0128 FDA UDI
Identifiers
- Catalog Number
- ROJS9530ST228 FDA UDI
- Primary DI / UDI-DI
- 03700512967491 FDA UDI
- 510(k) Number
- K173734 FDA UDI
- FDA Product Code
- FAD FDA UDI
- GMDN Term
- Polymeric ureteral stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polymeric ureteral stent
The LumaFlex Double J stent is a sterile, non-bioabsorbable ureteral stent designed for long-term implantation in obstructed ureters. With its unique design and durable construction, this device provides effective management of urine flow while maintaining luminal patency.
Similar devices
Also classified as Polymeric ureteral stent.
- Polaris™ Loop — Boston Scientific · Class II
- Percuflex™ Plus — Boston Scientific · Class II
- Percuflex™ Plus — Boston Scientific · Class II
- Polaris™ Ultra — Boston Scientific · Class II
- Q UROLOGICAL PERSISTENT AGUAMEDICINA — Q Urological Corporation · Class II
- Universa — COOK INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- TECOFLEX — Gyrus Acmi, Inc. · Class II
Cleared under the same submission
K173734 also covers:
- LumaFlex Double J stent, 2 open tips, Ch/Fr4, 8/L.22cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr4, 8/L.24cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr4, 8/L.26cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr4, 8/L.28cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.28cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.30cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.24cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.26cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.28cm, without wire — Promepla
- LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.30cm, without wire — Promepla
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Promepla
Sources (1)
- FDA UDI b4c2ec09-f104-48bf-8b2b-73091a82f505 35 fields · synced Jul 20, 2026