Identity
- Trade Name
- Vantage FDA UDI
- Generic Name
- Urinary stone retrieval basket, single-use FDA UDI
- Device Name
- 2.4 Fr, 90 cm, NiTi Tipless Stone Basket FDA UDI
- Model / Reference
- 550310 FDA UDI
- Description
- 2.4 Fr, 90 cm, NiTi Tipless Stone Basket FDA UDI
Identifiers
- Catalog Number
- 550310 FDA UDI
- Primary DI / UDI-DI
- B0325503100 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
Vantage 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 fc0e0926-bf70-4790-92b7-c94e1eea18c9 35 fields · synced Jun 8, 2026