Identity
- Trade Name
- IMAGE DIAGNOSTICS INC FDA UDI
- Generic Name
- Basic diagnostic x-ray system table, powered FDA UDI
- Device Name
- IDI,PROTEGO "PRO" PROCEDURE KIT,CASE OF 25 POUCHES,#A800-0310 FDA UDI
- Model / Reference
- PRO KIT, CASE FDA UDI
- Description
- IDI,PROTEGO "PRO" PROCEDURE KIT,CASE OF 25 POUCHES,#A800-0310 FDA UDI
Identifiers
- Catalog Number
- A800-0310 FDA UDI
- Primary DI / UDI-DI
- 00850977007898 FDA UDI
- FDA Product Code
- MMP FDA UDI
- GMDN Term
- Basic diagnostic x-ray system table, powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic diagnostic x-ray system table, powered
Image Diagnostics Inc by Image Diagnostics, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Image Diagnostics, Inc.
Sources (1)
- FDA UDI a09dc88a-3a41-43d8-9c20-09bac31adef1 35 fields · synced May 30, 2026