FDA.reportPublic FDA data

FENTEX

Primary DI
04250407738334
Brand
FENTEX
Company
FENTEX medical GmbH
Model
469110FX
Catalog number
469110FX
Device description
Tracheal Trocar by Denker (Uckermann) 13 cm, Ø 9 mm
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
04250407738334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407738334042504077383344250407738334

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal trocar bladeA hand-held manual surgical instrument with a sharp pyramidal or conical point designed to puncture the trachea during tracheotomy. It is typically assembled and used with a compatible tube (not included), e.g., a tube identical to that of a tracheostomy tube, filling its lumen, thereby allowing the introduction of this assembly. Following puncture, the trocar is withdrawn providing a stoma through which the patient can breathe. 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
04250407737245FENTEX443530FX443530FX2022-12-12
04250407772727FENTEX443516FX443516FX2022-12-12
04250407772840FENTEX443514FX443514FX2022-12-12
04250407774301FENTEX443512FX443512FX2022-12-12
04250407774318FENTEX443511FX443511FX2022-12-12
04250407774325FENTEX443510FX443510FX2022-12-12
04250407774332FENTEX443509FX443509FX2022-12-12
04250407774349FENTEX443539FX443539FX2022-12-12
04250407775131FENTEX443531FX443531FX2022-12-12
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

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