Identity
- Trade Name
- Fusion FDA UDI
- Generic Name
- Biliary/urinary stone retrieval basket, single-use FDA UDI
- Device Name
- Fusion Lithotripsy Extraction Basket FDA UDI
- Model / Reference
- G48277 FDA UDI
- Description
- Fusion Lithotripsy Extraction Basket FDA UDI
Identifiers
- Catalog Number
- FS-LXB-2X4 FDA UDI
- Primary DI / UDI-DI
- 00827002482777 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
Yes
FDA UDI
Category: Biliary/urinary stone retrieval basket, single-use
Fusion by Cook, Inc. — 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
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- 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
- Cook, Inc.
Sources (1)
- FDA UDI 418f6a1f-f90f-4d70-b465-32f32914af05 36 fields · synced Jun 6, 2026