Identity
- Trade Name
- StabilICE FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- StabilICE FDA UDI
- Model / Reference
- 900221 FDA UDI
- Description
- StabilICE FDA UDI
Identifiers
- Catalog Number
- 900221 FDA UDI
- Primary DI / UDI-DI
- 00850027837642 FDA UDI
- FDA Product Code
- HYA FDA UDIDWS FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted 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
Yes
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 1a142af2-64b8-405b-a758-f8241d1e3f2a 36 fields · synced May 30, 2026