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Ergon Boom Series

FDA UDI

Class I (US FDA UDI)

by Skytron, LLC

Identity

Trade Name
Ergon Boom Series FDA UDI
Generic Name
Operating room light system FDA UDI
Device Name
Lightweight Central Mount with optional surgical lighting. FDA UDI
Model / Reference
Ergon 2 FDA UDI
Description
Lightweight Central Mount with optional surgical lighting. FDA UDI

Identifiers

Catalog Number
E2 110 Series FDA UDI
Primary DI / UDI-DI
10841736100636 FDA UDI
FDA Product Code
FQO FDA UDI
FSY FDA UDI
GMDN Term
Operating room light system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4960 FDA UDI
878.4580 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

No

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 I — 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 95e7407f-448d-4c3d-8a2a-32304079dbae 36 fields · synced May 31, 2026