FDA.reportPublic FDA data

FENTEX

Primary DI
04250407742232
Brand
FENTEX
Company
FENTEX medical GmbH
Model
532117FX
Catalog number
532117FX
Device description
Laryngeal Knife golf stick shaped WL 23 cm
Published
2022-12-12
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
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
04250407742232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407742232042504077422324250407742232

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal knifeA hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250407715588FENTEX154100FX154100FX2022-12-08
04250407715595FENTEX154200FX154200FX2022-12-08
04250407715601FENTEX154300FX154300FX2022-12-08
04250407715618FENTEX154400FX154400FX2022-12-08
04250407715625FENTEX154500FX154500FX2022-12-08
04250407715632FENTEX154600FX154600FX2022-12-08
04250407715649FENTEX154700FX154700FX2022-12-08
04250407715663FENTEX154800FX154800FX2022-12-08
04250407715670FENTEX155102FX155102FX2022-12-08
04250407715687FENTEX155104FX155104FX2022-12-08
04250407715694FENTEX155105FX155105FX2022-12-08
04250407715700FENTEX155106FX155106FX2022-12-08
04250407715717FENTEX155108FX155108FX2022-12-08
04250407715724FENTEX155110FX155110FX2022-12-08
04250407715731FENTEX155112FX155112FX2022-12-08
04250407715748FENTEX155115FX155115FX2022-12-08
04250407715755FENTEX155120FX155120FX2022-12-08
04250407715779FENTEX155125FX155125FX2022-12-08
04250407715786FENTEX155130FX155130FX2022-12-08
04250407715823FENTEX156102FX156102FX2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250407741976FENTEXFENTEX medical GmbHLRC2023-06-14
04250407729448FENTEXFENTEX medical GmbHLRC2022-12-12
04250407730406FENTEXFENTEX medical GmbHLRC2022-12-12
04250407731328FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732288FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732295FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732332FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732912FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732929FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732936FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732943FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732950FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733063FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733865FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733872FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734282FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734466FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734473FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734480FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734497FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734794FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734947FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734954FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734961FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734978FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734985FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734992FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735005FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735203FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735210FENTEXFENTEX medical GmbHLRC2022-12-12