Identity
- Trade Name
- StabilICE FDA UDI
- Generic Name
- General surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- StabilICE FDA UDI
- Model / Reference
- 900218 FDA UDI
- Description
- StabilICE FDA UDI
Identifiers
- Catalog Number
- 900218 FDA UDI
- Primary DI / UDI-DI
- 00850027837529 FDA UDI
- FDA Product Code
- HYA FDA UDIDWS FDA UDI
- GMDN Term
- General surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI870.4500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
StabilICE by Acutus Medical, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Acutus Medical, Inc.
Sources (1)
- FDA UDI 4a3dc281-3b2b-482b-9933-dcde139aaf9c 36 fields · synced May 30, 2026