Identity
- Trade Name
- CardioMD FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- Gamma Camera System FDA UDI
- Model / Reference
- CardioMD Gamma Camera System FDA UDI
- Description
- Gamma Camera System FDA UDI
Identifiers
- Catalog Number
- 9PMS3060 FDA UDI
- Primary DI / UDI-DI
- 05711665002029 FDA UDI
- 510(k) Number
- K011611 FDA UDI
- FDA Product Code
- KPS FDA UDI
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 284 Centimeter FDA UDIDepth — 150 Centimeter FDA UDIHeight — 150 Centimeter FDA UDIWeight — 815 Kilogram FDA UDI
CardioMD by Ddd-Diagnostic A/S — 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
- Ddd-Diagnostic A/S
Sources (1)
- FDA UDI 572aa905-2348-449b-a159-1cf096d22e53 38 fields · synced May 30, 2026