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
04046826047443Medicon44.90.7244.90.722026-07-31
04046826380830Medicon Tray906.90.57906.90.572026-07-30
04046826380939Medicon Tray906.90.76906.90.762026-07-30
04046826413187Medicon Tray906.92.05906.92.052026-07-30
04046826413194Medicon Tray906.92.06906.92.062026-07-30
04046826413200Medicon Tray906.92.08906.92.082026-07-30
04046826438180Medicon Tray906.92.18906.92.182026-07-30
04046826495800Medicon Tray906.91.32906.91.322026-07-30
04046826495954Medicon Tray906.91.87906.91.872026-07-30
04046826486228Medicon68.85.23A68.85.23A2026-07-29
04046826531478Medicon68.85.21A68.85.21A2026-07-29
04046826531485Medicon68.85.22A68.85.22A2026-07-29
04046826561741Medicon68.93.04A68.93.04A2026-07-29
04046826531454Medicon68.85.19A68.85.19A2026-07-28
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

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