Identity
- Trade Name
- IMAGE DIAGNOSTICS, INC FDA UDI
- Generic Name
- Radiation shielding panel, portable/mobile FDA UDI
- Device Name
- IDI,DUAL ARM SYSTEM,COMPASS FLEX,MOBILE,WITH 4500 LIGHT & COMPASS CONTOUR,32 HD MONITOR,#A280-1190 FDA UDI
- Model / Reference
- Compass Flex w/32" HD monitor FDA UDI
- Description
- IDI,DUAL ARM SYSTEM,COMPASS FLEX,MOBILE,WITH 4500 LIGHT & COMPASS CONTOUR,32 HD MONITOR,#A280-1190 FDA UDI
Identifiers
- Catalog Number
- A280-1190 FDA UDI
- Primary DI / UDI-DI
- 00850977007829 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
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
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 shielding panel, portable/mobile
Image Diagnostics, Inc by Image Diagnostics, 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
- Image Diagnostics, Inc.
Sources (1)
- FDA UDI 860287ff-e523-403b-96fe-74609f3994bf 35 fields · synced Jun 1, 2026