FDA.reportPublic FDA data

FENTEX

Primary DI
04250407721398
Brand
FENTEX
Company
FENTEX medical GmbH
Model
199600FX
Catalog number
199600FX
Device description
Temporal Bone Holder ***no medical device***
Published
2022-12-08
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
04250407721398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407721398042504077213984250407721398

GMDN Terms#

Term, Definition table
TermDefinition
Temporal bone holderA surgical device used to hold a piece of bone in a clamped position outside of the surgical field while the surgeon and/or other helping assistants work on it. It is typically used to reshape bone or for creating grafting material. This device will typically have a sturdy foot, a clamp to hold the bone, and an integral dish-like bowl to catch the bone fragments/cuttings. 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
04250407712372FENTEX118901FX118901FX2022-12-08
04250407712389FENTEX118902FX118902FX2022-12-08
04250407712396FENTEX118903FX118903FX2022-12-08
04250407712402FENTEX118904FX118904FX2022-12-08
04250407720650FENTEX185400FX185400FX2022-12-08
04250407721671FENTEX211616FX211616FX2022-12-09
04250407721688FENTEX211618FX211618FX2022-12-09
04250407723507FENTEX235001FX235001FX2022-12-09
04250407724580FENTEX236900FX236900FX2022-12-09
04250407724603FENTEX236902FX236902FX2022-12-09
04250407724634FENTEX237002FX237002FX2022-12-09
04250407725617FENTEX250208FX250208FX2022-12-09
04250407737535FENTEX446500FX446500FX2022-12-12
04250407737672FENTEX449200FX449200FX2022-12-12
04250407742003FENTEX532050FX532050FX2022-12-12
04250407742041FENTEX532080FX532080FX2022-12-12
04250407742058FENTEX532081FX532081FX2022-12-12
04250407744359FENTEX541105FX541105FX2022-12-12
04250407760557FENTEX412601FX412601FX2022-12-12
04250407761233FENTEX540511FX540511FX2022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250407765002FENTEXFENTEX medical GmbHLRC2023-04-04
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