Identity
- Trade Name
- ScatPad FDA UDI
- Generic Name
- Radiation shielding panel, portable/mobile FDA UDI
- Device Name
- SCATPAD SMA 123 Multipurpose Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Multipurpose Shield for IR, EP, Cath Lab & OR, Tri Level FDA UDI
- Model / Reference
- SMA 123 FDA UDI
- Description
- SCATPAD SMA 123 Multipurpose Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Multipurpose Shield for IR, EP, Cath Lab & OR, Tri Level FDA UDI
Identifiers
- Catalog Number
- SMA 123 FDA UDI
- Primary DI / UDI-DI
- 00814907020630 FDA UDI
- FDA Product Code
- IWX FDA UDI
- GMDN Term
- Radiation shielding panel, portable/mobile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Commercial Distribution
- 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
Ethylene Oxide FDA UDI
Category: Radiation shielding panel, portable/mobile
ScatPad by Cardio Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Cardio Medical Products, Inc.
Sources (1)
- FDA UDI c0ca12e6-d7ee-4ee2-8983-745306cc9402 36 fields · synced May 31, 2026