Identity
- Trade Name
- Extraction Basket FDA UDI
- Generic Name
- Biliary/urinary stone retrieval basket, single-use FDA UDI
- Device Name
- Nitinol Spiral Extraction Basket EUDAMEDBasket shape: Eight wires spiral; Basket Diameter: 30mm; Basket Length: 70mm; Working Length: 2000mm; FDA UDI
- Model / Reference
- RSEB-S8-30 EUDAMEDFDA UDI
- Description
- Basket shape: Eight wires spiral; Basket Diameter: 30mm; Basket Length: 70mm; Working Length: 2000mm; FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06902284566521 EUDAMED06932503511582 FDA UDI
- Basic UDI-DI
- 6902284EB464529K EUDAMED
- 510(k) Number
- K243471 FDA UDI
- FDA Product Code
- LQR FDA UDI
- EMDN Code
- G0305010201 DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, REVOLVING EUDAMED
- GMDN Term
- Biliary/urinary stone retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 2000 Millimeter FDA UDIOuter Diameter — 30 Millimeter FDA UDI
Category: Biliary/urinary stone retrieval basket, single-use
Extraction Basket by Micro-Tech (Nanjing) Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- Perc NCircle — COOK INCORPORATED · Class II
- Bean Smith Mahorner — COOK INCORPORATED · Class II
- Bard® SkyLite™ Tipless Nitinol Stone Basket — C. R. Bard, Inc. · Class II
- Stone Extraction Baskets — Changzhou Health Microport Medical Device Co., Ltd · Class II
- Cook — COOK INCORPORATED · Class II
- Memory Basket — COOK INCORPORATED · Class II
Cleared under the same submission
K243471 also covers:
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
- Extraction Basket — Micro-Tech (Nanjing) Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (2)
- FDA UDI b100e033-76a1-4610-b300-14ff05e0bdd9 36 fields · synced Jul 25, 2026
- EUDAMED 363e7567-849b-4525-b15a-206a0a4c6032 61 fields · synced Jul 25, 2026