DEVICE: Ergon Boom Series (10841736100896)
Device Identifier (DI) Information
Ergon Boom Series
Ergon 3
In Commercial Distribution
330 Series
SKYTRON LLC
Ergon 3
In Commercial Distribution
330 Series
SKYTRON LLC
Tandem Mount with optional surgical or exam lighting.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
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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? |
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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.
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Active | false |
12276 | Fixed examination/treatment room light |
A fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KZF | DEVICE, MEDICAL EXAMINATION, AC POWERED |
FQO | TABLE, OPERATING-ROOM, AC-POWERED |
FSY | Light, surgical, ceiling mounted |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 14 and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Temperature: between 14 and 140 Degrees Fahrenheit |
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5f569434-183c-456f-afe5-4f7c3f2db90d
January 08, 2021
3
September 19, 2016
January 08, 2021
3
September 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)759-8766
info@skytron.us
info@skytron.us