FDA.reportPublic FDA data

FENTEX

Primary DI
04250407700478
Brand
FENTEX
Company
FENTEX medical GmbH
Model
016104FX
Catalog number
016104FX
Device description
Eustachian Catheter by Hartmann size 4
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250407700478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407700478042504077004784250407700478

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
+4974679496212s.renner@fentexmedical.com

Regulatory Flags#

DUNS number
507221724
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250407788339FENTEX270263FX270263FX2025-12-30
04250407786847FENTEX540730FX540730FX2025-03-25
04250407786854FENTEX540732FX540732FX2025-03-25
04250407786861FENTEX540733FX540733FX2025-03-25
04250407786878FENTEX540734FX540734FX2025-03-25
04250407786885FENTEX540701FX540701FX2025-03-25
04250407786892FENTEX540702FX540702FX2025-03-25
04250407786908FENTEX540704FX540704FX2025-03-25
04250407778262FENTEX540780FX540780FX2025-02-19
04250407786663FENTEX118960FX118960FX2024-12-28
04250407786670FENTEX118970FX118970FX2024-12-28
04250407786731FENTEX540725FX540725FX2024-10-18
04250407786748FENTEX540726FX540726FX2024-10-18
04250407786755FENTEX540727FX540727FX2024-10-18
04250407786762FENTEX540728FX540728FX2024-10-18
04250407731571FENTEX363600FX363600FX2022-12-12
04250407731816FENTEX379100FX379100FX2022-12-12
04250407785116FENTEX540700FX540700FX2024-08-01
04250407785314FENTEX540705FX540705FX2024-08-01
04250407785321FENTEX540710FX540710FX2024-08-01

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09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
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