Identity
- Trade Name
- Ralco srl FDA UDI
- Generic Name
- Automatic-aperture-control diagnostic x-ray system collimator FDA UDI
- Model / Reference
- P 313/A DHHS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08058776050110 FDA UDI
- FDA Product Code
- IZW FDA UDI
- GMDN Term
- Automatic-aperture-control diagnostic x-ray system collimator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1610 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: Automatic-aperture-control diagnostic x-ray system collimator
Ralco srl by Ralco Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Automatic-aperture-control diagnostic x-ray system collimator.
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- R-300 — Shimadzu Corp. · Class II
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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
- Ralco Srl
Sources (1)
- FDA UDI a81b5fd9-1370-4ae5-a4a6-d03bc1003a9b 32 fields · synced Jun 8, 2026