FDA.reportPublic FDA data

AURORA SURGICAL LIGHT SERIES

Primary DI
10841736110536
Brand
AURORA SURGICAL LIGHT SERIES
Company
SKYTRON LLC
Model
AURORA ASTRO
Device description
LED MINOR PROCEDURE LIGHT
Published
2017-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSSLight, Surgical, Floor Standing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736110536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173611053610841736110536

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light standA mobile device designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. It is a mobile floor stand which may include wheels and/or articulated arms to enable dynamic positioning; the device to be supported (medical light/monitor) is not included.

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 Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078375583
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736124410Skytron 200 x 400 VESA Adapter Plate4A-VESA-200-400 Freedom4A-VESA-200-4002026-03-19
10841736125141CleanStartCSTART-7115CSTART-71152025-12-19
10841736125158CleanStartCSTART-7130CSTART-71302025-12-19
10841736125165CleanStartCSTART-8115CSTART-81152025-12-19
10841736125172CleanStartCSTART-8130CSTART-81302025-12-19
10841736125189CleanStartCSTART-8315CSTART-83152025-12-19
10841736125196CleanStartCSTART-8330CSTART-83302025-12-19
10841736125202CleanStartCSTART-9815CSTART-98152025-12-19
10841736125219CleanStartCSTART-9830CSTART-98302025-12-19
10841736124298Skytron LLC40-LC-ED40-LC-ED2025-12-09
10841736124427Sterling 1000-MIS-WA1000-MIS-WA2025-12-09
10841736124434Sterling 1800-MIS-WA1800-MIS-WA2025-12-09
10841736124861Skytron4-030-42-94-030-42-92025-12-03
10841736124878Skytron1-012-04-21-012-04-22025-12-03
10841736124885Skytron1-012-04-31-012-04-32025-12-03
10841736124892Skytron1-012-04-41-012-04-42025-12-03
10841736124908Skytron1-012-04-51-012-04-52025-12-03
10841736124915Skytron2-060-05-3S2-060-05-3S2025-12-03
10841736124939Skytron4-030-01-14-030-01-12025-12-03
10841736124946Skytron4-030-10-2WS4-030-10-2WS2025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855373008036NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
00855373008043NICO Corporation SUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
M678NN70640NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
M678NN90100NICOSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
20686864056816Medicom SafeMaskAMD Medicom IncFSS2025-01-23
03700712412029Maquet RoliteMAQUET SASFSS2024-11-07
04250613849282DM MS Sim.LED ExL DES.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849305MS Sim.LED OpL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849329MS Sim.LED OpL wDBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849367MS Sim.LED OpL USS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849404DM MS Sim.LED ExL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
03700712432508Maquet RoliteMAQUET SASFSS2024-06-20
03700712432522Maquet RoliteMAQUET SASFSS2024-06-20
03700712432515Maquet RoliteMAQUET SASFSS2024-02-02
24026704741834PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
03700712432539Maquet RoliteMAQUET SASFSS2023-12-15
03700712422745Maquet RoliteMAQUET SASFSS2023-09-19
03700712422752Maquet RoliteMAQUET SASFSS2023-09-19
03700712422769Maquet RoliteMAQUET SASFSS2023-09-19
03700712422776Maquet RoliteMAQUET SASFSS2023-09-19
03700712422783Maquet RoliteMAQUET SASFSS2023-09-19
03700712422790Maquet RoliteMAQUET SASFSS2023-09-19
03700712422806Maquet RoliteMAQUET SASFSS2023-09-19
03700712422813Maquet RoliteMAQUET SASFSS2023-09-19
03700712422820Maquet RoliteMAQUET SASFSS2023-09-19
03700712422837Maquet RoliteMAQUET SASFSS2023-09-19
03700712422844Maquet RoliteMAQUET SASFSS2023-09-19
03700712422851Maquet RoliteMAQUET SASFSS2023-09-19
00887761968554Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFSS2023-07-11
03700712422707Maquet RoliteMAQUET SASFSS2023-05-26