Identity
- Trade Name
- allSoft FDA UDI
- Generic Name
- Polymeric ureteral stent FDA UDI
- Device Name
- allSoft Pediatric Ureteral Stents Open Tip 4F, 12cm with Guidewire FDA UDI
- Model / Reference
- allSoft Pediatric Ureteral Stents Open Tip 4F, 12cm with Guidewire FDA UDI
- Description
- allSoft Pediatric Ureteral Stents Open Tip 4F, 12cm with Guidewire FDA UDI
Identifiers
- Catalog Number
- POS4/12-G FDA UDI
- Primary DI / UDI-DI
- 00812261010953 FDA UDI
- 510(k) Number
- K190659 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
No
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
Yes
FDA UDI
Category: Polymeric ureteral stent
allSoft by Allwin Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric ureteral stent.
- Polaris™ Loop — Boston Scientific · Class II
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- 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
K190659 also covers:
- All Soft Ureteral Stent - 6F, 22cm with Suture — ALLWIN MEDICAL DEVICES, INC.
- All Soft Ureteral Stent - 6F, 24cm — ALLWIN MEDICAL DEVICES, INC.
- All Soft Ureteral Stent - 6F, 24cm with Suture — ALLWIN MEDICAL DEVICES, INC.
- All Soft Ureteral Stent - 6F, 26cm — ALLWIN MEDICAL DEVICES, INC.
- All Soft Ureteral Stent - 6F, 26cm with Suture — ALLWIN MEDICAL DEVICES, INC.
- All Soft Ureteral Stent - 7F, 22cm with Suture — ALLWIN MEDICAL DEVICES, INC.
- All Soft Ureteral Stent - 7F, 24cm with Suture — ALLWIN MEDICAL DEVICES, INC.
- All Soft Ureteral Stent - 7F, 26cm with Suture — ALLWIN MEDICAL DEVICES, INC.
- R+ — ALLWIN MEDICAL DEVICES, INC.
- R+ — ALLWIN MEDICAL DEVICES, INC.
- R+ — ALLWIN MEDICAL DEVICES, INC.
- R+ — ALLWIN MEDICAL DEVICES, INC.
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
- Allwin Medical Devices, Inc.
Sources (1)
- FDA UDI 27e67278-ce59-4c9e-aa4f-9b1e1ce1f261 36 fields · synced May 31, 2026