Identity
- Trade Name
- Skytron FDA UDI
- Generic Name
- Fluoroscopy/angiography table top FDA UDI
- Device Name
- 1/2 Inch X-RAY TOP SET 6500-HD FDA UDI
- Model / Reference
- 5-010-14-B FDA UDI
- Description
- 1/2 Inch X-RAY TOP SET 6500-HD FDA UDI
Identifiers
- Catalog Number
- 5-010-14-B FDA UDI
- Primary DI / UDI-DI
- 10841736122744 FDA UDI
- FDA Product Code
- FQO FDA UDI
- GMDN Term
- Fluoroscopy/angiography table top FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Skytron by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Skytron, LLC
Sources (1)
- FDA UDI e4ef099e-43c7-4c14-81fc-fd02f6d2c496 37 fields · synced May 30, 2026