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XenX – Stone Management Device (7 cm tip Proximal Stone)
FDA UDIClass II (US FDA UDI)
by Promepla
Identity
- Trade Name
- XenX – Stone Management Device (7 cm tip Proximal Stone) FDA UDI
- Generic Name
- Biliary/urinary stone retrieval basket, single-use FDA UDI
- Model / Reference
- ROXE03807ST FDA UDI
Identifiers
- Catalog Number
- ROXE03807ST FDA UDI
- Primary DI / UDI-DI
- 03700512965237 FDA UDI
- 510(k) Number
- K123438 FDA UDI
- FDA Product Code
- OCY FDA UDIFFL FDA UDI
- GMDN Term
- Biliary/urinary stone retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI876.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Biliary/urinary stone retrieval basket, single-use
XenX – Stone Management Device (7 cm tip Proximal Stone) by Promepla — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biliary/urinary stone retrieval basket, single-use.
- Rutner — COOK INCORPORATED · Class II
- Stone Extraction Baskets — Changzhou Health Microport Medical Device Co., Ltd · Class II
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Perc NCircle — COOK INCORPORATED · Class II
- eyeMAX(TM) Extraction Basket — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Bean Smith Mahorner — COOK INCORPORATED · Class II
- eyeMAX(TM) Extraction Basket — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Bard® SkyLite™ Tipless Nitinol Stone Basket — C. R. Bard, Inc. · Class II
Cleared under the same submission
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 22a1c38e-6bb8-4a6b-b634-417a71b6f7eb 35 fields · synced Jun 6, 2026