Skytron

FDA UDI

Class I (US FDA UDI)

by Skytron, LLC

Identity

Trade Name: Skytron FDA UDI
Generic Name: Fluoroscopy/angiography table top FDA UDI
Device Name: 1/2 Inch X-RAY TOP HEAD SECTION 3600/6700 FDA UDI
Model / Reference: 5-010-21-1B FDA UDI
Description: 1/2 Inch X-RAY TOP HEAD SECTION 3600/6700 FDA UDI

Identifiers

Catalog Number: 5-010-21-1B FDA UDI
Primary DI / UDI-DI: 10841736122881 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Fluoroscopy/angiography table top

Skytron by Skytron, LLC — 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: Skytron, LLC

Sources (1)

FDA UDI 43dd5ee5-7d6b-4027-89ea-5efa057d6c70 36 fields · synced Jun 8, 2026