DEVICE: Ergon Boom Series (10841736100643)
Device Identifier (DI) Information
Ergon Boom Series
Ergon 2
In Commercial Distribution
E2 120 Series
SKYTRON LLC
Ergon 2
In Commercial Distribution
E2 120 Series
SKYTRON LLC
Lightweight Central Tandem Mount with optional surgical lighting.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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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.
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FSY | Light, surgical, ceiling mounted |
FQO | TABLE, OPERATING-ROOM, AC-POWERED |
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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Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 14 and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
61c88a05-51aa-4f4e-8681-2b3368981f8f
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