FDA.reportPublic FDA data

FIBER ESOPHAGOSCOPE

Primary DI
04961333232741
Brand
FIBER ESOPHAGOSCOPE
Company
PENTAX OF AMERICA, INC.
Model
FE-15W
Device description
FIBER TRANS N ESOPH (REFURBISHED)
Published
2017-04-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCLEsophagoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCLEsophagoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333232741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333232741049613332327414961333232741

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic oesophagoscopeAn endoscope with a flexible inserted portion intended the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine abnormalities in the tissue structure and mucous lining. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""High-level Disinfectant""]"
Ethylene Oxide;High-level Disinfectant

Regulatory Flags#

DUNS number
083211284
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16971381251613Single-use Biopsy ForcepsSCIVITA MEDICAL TECHNOLOGY CO., LTD.GCL2023-05-24
00812608021581PMIPROGRESSIVE MEDICAL, INC.GCL2017-10-04
10812608021588PMIPROGRESSIVE MEDICAL, INC.GCL2017-10-04
04961333224722PENTAXHOYA CORPORATIONGCL2017-04-07
04961333224746PENTAXHOYA CORPORATIONGCL2017-04-07
04961333224784PENTAXHOYA CORPORATIONGCL2017-04-07
04961333224807PENTAXHOYA CORPORATIONGCL2017-04-07
04961333227471PENTAXHOYA CORPORATIONGCL2017-04-07
04961333227495PENTAXHOYA CORPORATIONGCL2017-04-07
04961333227518PENTAXHOYA CORPORATIONGCL2017-04-07
04961333227532PENTAXHOYA CORPORATIONGCL2017-04-07
00812608021314PMIPROGRESSIVE MEDICAL, INC.GCL2016-09-23
00812608021376PMIPROGRESSIVE MEDICAL, INC.GCL2016-09-23