Identity
- Trade Name
- Standard Imaging Exradin A28 Ion Chamber FDA UDI
- Generic Name
- Radiation condenser R-meter FDA UDI
- Device Name
- Standard Imaging Exradin A28 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDI
- Model / Reference
- 92749 FDA UDI
- Description
- Standard Imaging Exradin A28 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental). FDA UDI
Identifiers
- Catalog Number
- 92749 FDA UDI
- Primary DI / UDI-DI
- 00850019946390 FDA UDI
- FDA Product Code
- LHO FDA UDI
- GMDN Term
- Radiation condenser R-meter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1940 FDA UDI
- Commercial Distribution
- 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation condenser R-meter
Standard Imaging Exradin A28 Ion Chamber by Standard Imaging, 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
- Standard Imaging, Inc.
Sources (1)
- FDA UDI 6af10edf-0f42-4d23-8af2-05b3017434f2 34 fields · synced May 30, 2026