FDA.reportPublic FDA data

FENTEX

Primary DI
04250407703172
Brand
FENTEX
Company
FENTEX medical GmbH
Model
034802FX
Catalog number
034802FX
Device description
Ear Knife by Politzer curved 16 cm
Published
2022-12-07
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
04250407703172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407703172042504077031724250407703172

GMDN Terms#

Term, Definition table
TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. 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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Primary DI, Brand, Company table
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08904461031073OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
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09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
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00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
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