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Nitinol Stone Extractor, TIPLESS basket 4 wires, 2.2 Fr
FDA UDIClass II (US FDA UDI)
by Promepla
Identity
- Trade Name
- Nitinol Stone Extractor, TIPLESS basket 4 wires, 2.2 Fr FDA UDI
- Generic Name
- Biliary/urinary stone retrieval basket, single-use FDA UDI
- Model / Reference
- 09-0028 FDA UDI
Identifiers
- Catalog Number
- ROSZ2200ST FDA UDI
- Primary DI / UDI-DI
- 03700512966326 FDA UDI
- FDA Product Code
- FFL FDA UDI
- GMDN Term
- Biliary/urinary stone retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4680 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
Yes
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
Nitinol Stone Extractor, TIPLESS basket 4 wires, 2.2 Fr 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
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 d0970f34-4b8d-41c1-846a-ca210136a134 34 fields · synced Jun 8, 2026