FDA.reportPublic FDA data

FNS-3200

Primary DI
B366FE1021RX1
Brand
FNS-3200
Company
Ecleris
Model
RX1
Catalog number
FE102/1
Device description
Laringoscope Non Rigid 3,2 mm.
Published
2024-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CALLaryngoscope, Non-Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CALLaryngoscope, Non-RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B366FE1021RX1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video laryngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the larynx. It is inserted into the body through the mouth during laryngoscopy. Anatomical images are transmitted to the user by a video system at the distal end of the endoscope with the images showing on a monitor. This device is commonly used to evaluate or operate on laryngeal strictures, foreign bodies, or neoplasms; it is not intended for intubation of an artificial airway. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0 KiloPascal100 KiloPascal
Handling Environment Humidity40 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius36 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal100 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
786-483-7490ytzielo@ecleris.com

Regulatory Flags#

DUNS number
043555079
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B366U1VI360R04Procam HD CMOS IIR04U1VI3602026-05-27
B366U1VI3605PROCAM 4K USBRX1VI360/52026-05-19
B366LED0204R00PORTALEDR00LED020/42026-02-11
B366U1C200FR01MICROSCOPE ColposcopeR01U1C200F2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeR01U1C200T2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeR01U1C200W2024-02-13
B366HC200AR00MICROSCOPE ColposcopeR00HC200A2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeR00U1C200A2024-11-25
B366U1C200FR00MICROSCOPE ColposcopeR00U1C200F2024-02-07
B366U1C200TR00MICROSCOPE ColposcopeR00U1C200T2024-02-07
B366U1C200WR00MICROSCOPE ColposcopeR00U1C200W2024-02-07
B366MC400MICROSTAR ColposcopeR02MC4002023-08-22
B366MC410MICROSTAR ColposcopeR00MC4102023-08-22
B366C100FHD1MICROSTAR ColposcopeR00C100FHD12023-08-18
B366SN0300140SinuscopeR00SN03001402023-08-18
B366SN0330140SinuscopeR00SN03301402023-08-18
B366SN0370140SinuscopeR00SN03701402023-08-18
B366SN0400175SinuscopeR00SN04001752023-08-18
B366SN0430175SinuscopeR00SN04301752023-08-18
B366SN0445175SinuscopeR00SN04451752023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551422533NAKarl Storz GmbH & Co. KGCAL2025-03-28
00850027066011TOAD™Wm & Dg, Inc.CAL2024-10-23
10850027066018TOAD™Wm & Dg, Inc.CAL2024-10-23
B366FE1022RX1FNS-2800EclerisCAL2024-08-09
00850027061009TOAD™Wm & Dg, Inc.CAL2024-08-07
10850027061006TOAD™Wm & Dg, Inc.CAL2024-08-07
08436041580485OptomicOPTOMIC ESPAÑA SACAL2024-08-01
06974599110539NAChangsha Magill Medical Technology Co., Ltd.CAL2024-03-22
06974599110546NAChangsha Magill Medical Technology Co., Ltd.CAL2024-03-22
06974723796011SensorendoSensorendo Medical Technology (Zhuhai) Co., Ltd.CAL2023-12-14
06974599110515NAChangsha Magill Medical Technology Co., Ltd.CAL2023-01-13
06974599110522NAChangsha Magill Medical Technology Co., Ltd.CAL2023-01-13
06970831723154InsighterShenzhen Insighters Medical Technology Co., Ltd.CAL2023-01-05
06970831723192InsighterShenzhen Insighters Medical Technology Co., Ltd.CAL2023-01-05
06974723791115SensorendoSensorendo Medical Technology (Zhuhai) Co., Ltd.CAL2022-11-11
06974723794413SensorendoSensorendo Medical Technology (Zhuhai) Co., Ltd.CAL2022-11-11
06974599110447NAChangsha Magill Medical Technology Co., Ltd.CAL2022-08-23
06974599110003NAChangsha Magill Medical Technology Co., Ltd.CAL2021-10-29
04045396021686ri-integral flex flexible blade with integrated F.Rudolf Riester GmbHCAL2021-07-19
B00500675A0AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675A10AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675B0AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675B10AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675BDEMO0AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675C0AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675C10AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675CASE0AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675LCD0AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675V0AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31
B00500675V10AincA®ANESTHESIA ASSOCIATES, INC.CAL2021-03-31