DEVICE: Ergon Boom Series (10841736100636)

Device Identifier (DI) Information

Ergon Boom Series
Ergon 2
In Commercial Distribution
E2 110 Series
SKYTRON LLC
10841736100636
GS1

1
078375583 *Terms of Use
Lightweight Central Mount with optional surgical lighting.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37332 Operating room light system
An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.
Active false
35630 General utility supply system, ceiling-mounted
An assembly of devices that form a permanent ceiling-mounted system that provides easy access to utilities/amenities (e.g., electricity, gas, or gas scavenging). It is used in the operating room (OR), examination rooms, the recovery department, the intensive care unit (ICU), and accident and emergency (A&E) rooms. It typically consists of a ceiling fixture support, equipped with moveable arms (often multi-jointed) and a pendant head. It can include an equipment carrier for mounting other medical devices.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FQO TABLE, OPERATING-ROOM, AC-POWERED
FSY Light, surgical, ceiling mounted
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between 14 and 140 Degrees Fahrenheit
Handling Environment Temperature: between 14 and 140 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

95e7407f-448d-4c3d-8a2a-32304079dbae
January 08, 2021
3
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)759-8766
info@skytron.us
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