FDA.reportPublic FDA data

FENTEX

Primary DI
04250407722548
Brand
FENTEX
Company
FENTEX medical GmbH
Model
227102FX
Catalog number
227102FX
Device description
Nasal Forceps by Takahashi 45° upturned WL 11 cm, spoon 10 x 3 mm
Published
2022-12-09
Public version status
Update
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
04250407722548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407722548042504077225484250407722548

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
04250407712549FENTEX120202FX120202FX2022-12-08
04250407712556FENTEX120203FX120203FX2022-12-08
04250407712563FENTEX120204FX120204FX2022-12-08
04250407712570FENTEX120206FX120206FX2022-12-08
04250407712587FENTEX120208FX120208FX2022-12-08
04250407712594FENTEX120210FX120210FX2022-12-08
04250407713577FENTEX135100FX135100FX2022-12-08
04250407713584FENTEX135101FX135101FX2022-12-08
04250407713591FENTEX135102FX135102FX2022-12-08
04250407713607FENTEX135103FX135103FX2022-12-08
04250407714123FENTEX137101FX137101FX2022-12-08
04250407714130FENTEX137102FX137102FX2022-12-08
04250407714147FENTEX137103FX137103FX2022-12-08
04250407714192FENTEX142100FX142100FX2022-12-08
04250407714208FENTEX142101FX142101FX2022-12-08
04250407714215FENTEX142102FX142102FX2022-12-08
04250407714222FENTEX142103FX142103FX2022-12-08
04250407714314FENTEX142120FX142120FX2022-12-08
04250407714369FENTEX142130FX142130FX2022-12-08
04250407714581FENTEX143101FX143101FX2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250407721749FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721756FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721770FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721787FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721794FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721831FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721862FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721879FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721916FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721923FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722036FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722043FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722050FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722067FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722388FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722395FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722401FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722418FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722425FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722432FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722456FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722463FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722470FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722487FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722494FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722500FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722517FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722524FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722531FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722586FENTEXFENTEX medical GmbHLRC2022-12-09