Identity
- Trade Name
- QuadraSphere® FDA UDI
- Generic Name
- Embolization particle, non-bioabsorbable FDA UDI
- Model / Reference
- 00884450275184 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450275184 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Embolization particle, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Embolization particle, non-bioabsorbable
QuadraSphere® by Biosphere Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Embolization particle, non-bioabsorbable.
- Embozene Microspheres (Opaque) — Celonova Biosciences, Inc. · Class II
- Embozene Microspheres (Opaque) — Celonova Biosciences, Inc. · Class II
- Embozene® — Boston Scientific · Class II
- Contour™ — Boston Scientific · Class II
- Embozene® — Boston Scientific · Class II
- Embozene Microspheres (Opaque) — Celonova Biosciences, Inc. · Class II
- Embozene Microspheres (Color-Advanced) — Celonova Biosciences, Inc. · Class II
- HydroPearl — MICROVENTION 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosphere Medical, Inc.
Sources (1)
- FDA UDI d3eb8dcb-0b4c-47b9-a447-5797d7791045 33 fields · synced May 30, 2026