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LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.28cm, without wire
FDA UDIClass II (US FDA UDI)
by Promepla
Identity
- Trade Name
- LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.28cm, without wire FDA UDI
- Generic Name
- Polymeric ureteral stent FDA UDI
- Model / Reference
- 09-0131 FDA UDI
Identifiers
- Catalog Number
- ROJS9628ST228 FDA UDI
- Primary DI / UDI-DI
- 03700512967521 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
A comprehensive medical device directory entry for the LumaFlex Double J stent, a 2 open tip ureteral stent with features designed to improve urinary outcomes in patients with obstructed ureters.
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/Fr4, 8/L.30cm, 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.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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Promepla
Sources (1)
- FDA UDI b8d8ae69-379b-4fa6-91ad-a704f40c46b9 35 fields · synced Jul 9, 2026