gudid
Primary ID: 004
D-SPECT Cardio (UDI 004)
Manufactured by SPECTRUM DYNAMICS MEDICAL, INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for D-SPECT Cardio - Primary ID 004
Device Regulatory Overview
The D-SPECT Cardio (Model/Catalog Number: 004) is a medical device manufactured by SPECTRUM DYNAMICS MEDICAL, INC. This product is indexed under FDA Product Code / Category Classification KPS within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 004
- Product Code / EMDN
- KPS
- Device Name
- Single Photon Emission Computed Tomography system, 110V
- Database Sync Date
- 2026-08-09 09:18:16
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of D-SPECT Cardio?
The registered manufacturer of record for D-SPECT Cardio is SPECTRUM DYNAMICS MEDICAL, INC.
What is the Primary UDI-DI identifier for D-SPECT Cardio?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 004.
What classification code is assigned to this device?
This device is registered under product classification code KPS.
Similar Classification Devices (KPS)
Other Devices by SPECTRUM DYNAMICS MEDICAL, INC
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