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Ergon Boom Series

FDA UDI

Class II (US FDA UDI)

by Skytron, LLC

Identity

Trade Name
Ergon Boom Series FDA UDI
Generic Name
General utility supply system, ceiling-mounted FDA UDI
Device Name
Central Tandem Mount with Lightweight Arm with optional surgical or exam lighting. . FDA UDI
Model / Reference
Ergon 3 FDA UDI
Description
Central Tandem Mount with Lightweight Arm with optional surgical or exam lighting. . FDA UDI

Identifiers

Catalog Number
320 Series FDA UDI
Primary DI / UDI-DI
10841736100889 FDA UDI
FDA Product Code
FSY FDA UDI
FQO FDA UDI
KZF FDA UDI
GMDN Term
General utility supply system, ceiling-mounted FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 FDA UDI
878.4960 FDA UDI
880.6320 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

No

FDA UDI

Category: Operating room light systemGeneral utility supply system, ceiling-mounted

Ergon Boom Series by Skytron, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General utility supply system, ceiling-mounted.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Skytron, LLC

Sources (1)

  • FDA UDI 70033182-d3bf-416a-bf81-4b061489e0f1 36 fields · synced Jun 6, 2026