FDA.report

EVERLUX LIGHT SOURCE

Primary DI
B366U1LED100G22C03
Brand
EVERLUX LIGHT SOURCE
Company
Ecleris
Model
R00
Catalog number
U1LED100G22C03
Device description
EVERLUX LIGHT SOURCE
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NTNLed Light Source

Product Code Classifications

CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B366U1LED100G22C03PrimaryHIBCC0

GMDN Terms

TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity35 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
786-483-7490ytzielo@ecleris.com

Regulatory Flags

DUNS number
043555079
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
B366LED0204R00PORTALEDR00LED020/42026-02-11
B366U1C200FR01MICROSCOPE ColposcopeR01U1C200F2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeR01U1C200T2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeR01U1C200W2024-02-13
B366LED0204PORTALEDRX1LED020/42026-01-23
B366U1HC130G21Procam 4KR00U1HC130G212025-12-22
B366U1VI3701Procam 4KR00U1VI37012025-12-22
B366AIO100BRX1PROCAM PACKRX1AIO100B2025-08-22
B366AIO100SRX1PROCAM PACK SRX1AIO100S2025-08-22
B366FE1023RX1PROCAM FLEXRX1FE102/32025-08-22
B366U1VI2512R01PROCAM HD BASICR01U1VI25122025-08-22
B366U1VI360100BRX1PROCAM PACKRX1VI360/100B2025-08-22
B366U1VI360100SRX1PROCAM PACK SRX1VI360/100S2025-08-22
B366U1VI3604RX1PROCAM HD USBRX1VI360/42025-08-22
B366U1HC120G21R06Procam HD CMOS II CONSOLER06U1HC120G212025-07-30
B366U1VI3601R04Procam HD CMOS IIR04U1VI3602025-07-30
B366U1VI3603RX2Procam HD IIRX2U1VI36032025-07-30
B366U1C200AR01MICROSCOPE ColposcopeR01U1C200A2025-07-24
B366U1C200FR02MICROSCOPE ColposcopeR02U1C200F2025-07-24
B366U1C200TR02MICROSCOPE ColposcopeR02U1C200T2025-07-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00851289007354FireflyFirefly GlobalNTN2025-07-18
00857556008642BR Surgical, LLCBR Surgical, LLCNTN2025-07-16
04580137732617MACHIDAMACHIDA ENDOSCOPE CO.,LTD.NTN2025-03-27
04250480100271NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100288NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100295NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100325NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100349NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100356NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100363NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480101735NASCHÖLLY FIBEROPTIC GmbHNTN2024-12-03
04048551317488n.aKarl Storz GmbH & Co. KGNTN2024-11-29
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2024-11-14
00840183528522BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183528539BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183500474BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00857556008567BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00840183500023BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
00840183500047BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
06973031299894WhtNavi Light SourceGuangdong Optomedic Technologies, Inc.NTN2024-03-26
08033638801055Pen LEDSAPI MED SPANTN2023-08-02
04250369706747ILOILO electronic GmbHNTN2023-06-22
04250369706754ILOILO electronic GmbHNTN2023-06-22
04250369706761ILOILO electronic GmbHNTN2023-06-22
04250369706778ILOILO electronic GmbHNTN2023-06-22
04250369706785ILOILO electronic GmbHNTN2023-06-22
04250369706792ILOILO electronic GmbHNTN2023-06-22
04250369708352ILOILO electronic GmbHNTN2023-06-22
06971381250114LED Light SourceSCIVITA MEDICAL TECHNOLOGY CO., LTD.NTN2023-05-17
04049047657545NAGimmi GmbHNTN2023-05-03