FDA.reportPublic FDA data

Ergon Boom Series

Primary DI
10841736100889
Brand
Ergon Boom Series
Company
SKYTRON LLC
Model
Ergon 3
Catalog number
320 Series
Device description
Central Tandem Mount with Lightweight Arm with optional surgical or exam lighting. .
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTABLE, OPERATING-ROOM, AC-POWERED
FSYLight, surgical, ceiling mounted
KZFDEVICE, MEDICAL EXAMINATION, AC POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736100889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173610088910841736100889

GMDN Terms#

Term, Definition table
TermDefinition
General utility supply system, ceiling-mountedAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736117085Skytron1-011-01-211-011-01-212022-01-29
10841736117092Skytron1-011-01-221-011-01-222022-01-29
10841736117108Skytron1-011-01-31-011-01-32022-01-29
10841736117115Skytron1-011-01-41-011-01-42022-01-29
10841736117122Skytron1-011-01-51-011-01-52022-01-29
10841736117283Skytron1-011-02-421-011-02-422022-01-29
10841736117313Skytron1-011-02-521-011-02-522022-01-29
10841736117351Skytron1-011-03-51-011-03-52022-01-29
10841736117375Skytron1-011-04-221-011-04-222022-01-29
10841736117382Skytron1-011-04-231-011-04-232022-01-29
10841736117412Skytron1-011-04-431-011-04-432022-01-29
10841736117429Skytron1-011-04-51-011-04-52022-01-29
10841736117443Skytron1-011-05-211-011-05-212022-01-29
10841736117450Skytron1-011-05-221-011-05-222022-01-29
10841736117498Skytron1-011-05-51-011-05-52022-01-29
10841736117603Skytron1-011-06-311-011-06-312022-01-29
10841736117658Skytron1-011-06-3B1-011-06-3B2022-01-29
10841736117726Skytron1-011-06-421-011-06-422022-01-29
10841736117801Skytron1-011-07-211-011-07-212022-01-29
10841736117825Skytron1-011-07-41-011-07-42022-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
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03700712436315VolistaMAQUET SASFSY2026-07-20
03700712436322VolistaMAQUET SASFSY2026-07-20
03700712436339VolistaMAQUET SASFSY2026-07-20
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03700712436353VolistaMAQUET SASFSY2026-07-20