Identity
- Trade Name
- Summit FDA UDI
- Generic Name
- Urinary stone retrieval basket, single-use FDA UDI
- Device Name
- 3.0 Fr, 90 cm, Stainless Steel Flat Wire Stone Basket with Filiform Tip FDA UDI
- Model / Reference
- 342515 FDA UDI
- Description
- 3.0 Fr, 90 cm, Stainless Steel Flat Wire Stone Basket with Filiform Tip FDA UDI
Identifiers
- Catalog Number
- 342515 FDA UDI
- Primary DI / UDI-DI
- B0323425150 FDA UDI
- FDA Product Code
- FFL FDA UDI
- GMDN Term
- Urinary stone retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4680 FDA UDI
- Commercial Distribution
- Not 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
No
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
Summit by Sacred Heart Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sacred Heart Medical, Inc.
Sources (1)
- FDA UDI eea925ed-1f73-4129-a74a-61752de57a75 35 fields · synced Jun 6, 2026