Identity
- Trade Name
- Regard™ FDA UDI
- Generic Name
- Fluid/device delivery cardiac catheter FDA UDI
- Device Name
- PTCA CDS FDA UDI
- Model / Reference
- HT01170B FDA UDI
- Description
- PTCA CDS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10194717115809 FDA UDI
- GMDN Term
- Fluid/device delivery cardiac catheter FDA UDI
Classification
- 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
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 — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Roi Cps, Llc
Sources (1)
- FDA UDI 01282203-7a01-492b-a3ad-88767d715e6f 34 fields · synced May 30, 2026