FDA.report

EVERLUX PRO

Primary DI
B366U1LED121C03
Brand
EVERLUX PRO
Company
Ecleris
Model
R00
Catalog number
U1LED121C03
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

Product Codes

CodeName
EQHSource, Carrier, Fiberoptic Light

Product Code Classifications

CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B366U1LED121C03PrimaryHIBCC0

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 Celsius45 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

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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

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00198506088056ELMED INCORPORATEDELMED INCORPORATEDEQH2026-01-22
00198506087059ELMED INCORPORATEDELMED INCORPORATEDEQH2025-12-03
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00198506086908ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
04250676736000Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736024Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736031Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736055Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
00198506085079ELMED INCORPORATEDELMED INCORPORATEDEQH2025-09-05
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00190776406431MillenniumAvalign Technologies, Inc.EQH2025-07-21
00190776377137MillenniumAvalign Technologies, Inc.EQH2025-07-18
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00190776400019MillenniumAvalign Technologies, Inc.EQH2025-06-03
00198506083020ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-28
00198506083037ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-28
00198506082832ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-19
00190776394462MillenniumAvalign Technologies, Inc.EQH2025-05-07