FDA.reportPublic FDA data

MACHIDA

Primary DI
04580137730200
Brand
MACHIDA
Company
MACHIDA ENDOSCOPE CO.,LTD.
Model
ENT-3L
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EQNLaryngoscope, Nasopharyngoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQNLaryngoscope, NasopharyngoscopeEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K821182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821182000MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-Machida America, Inc.1982-05-13EQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580137730200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580137730200045801377302004580137730200

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic nasopharyngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690662549
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580137733195MACHIDAENT-30DA082025-04-01
04580137732617MACHIDARLED-302025-03-27
04580137730279MACHIDALY-CS302023-06-09
04580137733034MACHIDAENT-30VE2022-08-08
04580137733041MACHIDAVSP-20002022-08-08
04580137730217MACHIDAENT-4L2016-09-10
04580137732501MACHIDAENT-3C2016-09-10
04580137732518MACHIDAENT-2L2016-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B366FE1024RX1Nasopharyngoscope, FlexibleEclerisEQN2025-04-16
04580137733195MACHIDAMACHIDA ENDOSCOPE CO.,LTD.EQN2025-04-01
M6334281420JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-05-09
M6334941500JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-05-09
M6334942600JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-05-09
M6334942620JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-05-09
M6334942640JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-05-09
M6337099050JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099080JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099130JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M633709913QSV0JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099140JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099150JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099260JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099270JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099280JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099290JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099340JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099360JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099450JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099460JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099500JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099540JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-04-26
M6337099000JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08
M63349X40740JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08
M6337070170JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08
M6337070200JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08
M63370702010JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08
M63370702020JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08
M6337070400JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08