Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI
- Model / Reference
- OR00231J FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10194717103981 FDA UDI
- FDA Product Code
- OEZ FDA UDI
- GMDN Term
- Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Regard™ by Roi Cps, Llc — 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
- Roi Cps, Llc
Sources (1)
- FDA UDI d68e0365-6ad5-4ee7-9d3e-60fbf7a1f050 33 fields · synced Jun 1, 2026