Identity
- Trade Name
- Del Medical/Universal FDA UDI
- Generic Name
- X-ray system tube support, ceiling mounted FDA UDI
- Device Name
- An x-ray system component intended to be mounted to the ceiling, to support and facilitate position of the x-ray tube. The OTC18T allows for synchronized tracking but not stitching. FDA UDI
- Model / Reference
- OTC18T FDA UDI
- Description
- An x-ray system component intended to be mounted to the ceiling, to support and facilitate position of the x-ray tube. The OTC18T allows for synchronized tracking but not stitching. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858340006295 FDA UDI
- FDA Product Code
- IYB FDA UDI
- GMDN Term
- X-ray system tube support, ceiling mounted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1770 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
No
FDA UDI
Category: X-ray system tube support, ceiling mounted
Del Medical/Universal by Del Medical, 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
- Del Medical, Inc.
Sources (1)
- FDA UDI 912cb629-1d76-4062-80b1-23c7f3b1045d 33 fields · synced May 30, 2026