FDA.reportPublic FDA data

Medicon

Primary DI
04046826103446
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
62.20.14
Catalog number
62.20.14
Device description
Hartmann ear catheter fig 4 Ø 4.0mm
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYCCANNULA, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYCCannula, EarGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826103446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826103446040468261034464046826103446

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, reusableA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown from an external bag through the device and into the middle ear. It is typically made of soft metals [e.g., silver (Ag) coated brass], and has a curved distal end with a slightly bulbous tip and a wider funnel-like proximal end with a finger ring to aid manipulation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags#

DUNS number
315492330
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046826110833Medicon66.27.5366.27.532026-07-21
04046826346812Medicon68.86.89A68.86.89A2026-06-25
04046826416676Medicon68.87.28A68.87.28A2026-06-25
04046826542337Medicon68.86.4868.86.482026-06-25
04046826543655Medicon68.86.4968.86.492026-06-25
04046826552473Medicon68.93.4168.93.412026-06-25
04046826486631Stern-a-Fix Sternal Closure System54.81.0854.81.082026-06-24
04046826442842Medicon Tray906.91.16906.91.162026-06-22
04046826485429MediExpand Cervical Expandable VBR System405.06.38405.06.382026-06-22
04046826485436MediExpand Cervical Expandable VBR System405.06.58405.06.582026-06-22
04046826486020Medicon Tray906.91.36906.91.362026-06-22
04046826002572Medicon03.05.1703.05.172026-04-30
04046826020507Medicon14.06.1214.06.122026-04-30
04046826023331Medicon15.70.1415.70.142026-04-30
04046826023362Medicon15.71.1415.71.142026-04-30
04046826050849Medicon47.30.1347.30.132026-04-30
04046826063764Medicon51.99.5051.99.502017-05-31
04046826032807Medicon24.26.1224.26.122026-04-13
04046826531508Medicon68.94.70A68.94.70A2026-04-02
04046826531522Medicon68.94.72A68.94.72A2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G223130587410Medetz Surgical InstrumentsMedetz Surgical Instruments LLCJYC2023-06-08
00190660003906Ambler SurgicalAMBLER SURGICAL CORP.JYC2021-01-04
04046826103422MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
04046826103439MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
04046826103453MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
04046826103484MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
04046826103415MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
04046826103460MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
04046826103477MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
04046826103491MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
04046826103507MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYC2020-09-24
10885403009938V. MuellerSTERIS CORPORATIONJYC2018-07-13
10885403013089V. MuellerSTERIS CORPORATIONJYC2018-07-13
10885403013096V. MuellerSTERIS CORPORATIONJYC2018-07-13
10885403013102V. MuellerSTERIS CORPORATIONJYC2018-07-13
10885403013119V. MuellerSTERIS CORPORATIONJYC2018-07-13