FDA.reportPublic FDA data

FENTEX

Primary DI
04250407714628
Brand
FENTEX
Company
FENTEX medical GmbH
Model
143130FX
Catalog number
143130FX
Device description
Curette by Lempert 21 cm, size 000
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250407714628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407714628042504077146284250407714628

GMDN Terms#

Term, Definition table
TermDefinition
Adenoid curette, reusableA hand-held manual surgical instrument designed for cutting and excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge that is used to facilitate the removal of the tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the adenoids. 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

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