Identity
- Trade Name
- Extraction Basket FDA UDI
- Generic Name
- Biliary/urinary stone retrieval basket, single-use FDA UDI
- Device Name
- Basket shape: Four wires Hexagonal; Basket Diameter: 15mm; Basket Length: 40mm; Working Length: 2000mm; FDA UDI
- Model / Reference
- RSEB-H4-15 FDA UDI
- Description
- Basket shape: Four wires Hexagonal; Basket Diameter: 15mm; Basket Length: 40mm; Working Length: 2000mm; FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503511599 FDA UDI
- 510(k) Number
- K243471 FDA UDI
- FDA Product Code
- LQR FDA UDI
- GMDN Term
- Biliary/urinary stone retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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
Dimensions & Sizes
- Size
- Length — 2000 Millimeter FDA UDIOuter Diameter — 15 Millimeter FDA UDI
Category: Biliary/urinary stone retrieval basket, single-use
Extraction Basket by Micro-Tech (Nanjing) Co., Ltd. — 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
- 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 (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
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA UDI 06906eb7-2d5c-4fb8-824a-3a7c4a1ce348 36 fields · synced May 30, 2026