FDA.reportPublic FDA data

FENTEX

Primary DI
04250407730925
Brand
FENTEX
Company
FENTEX medical GmbH
Model
353103FX
Catalog number
353103FX
Device description
Nasal Rasp by Parkes coarse, with tungsten carbide inserts 20.5 cm, size 3
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
04250407730925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407730925042504077309254250407730925

GMDN Terms#

Term, Definition table
TermDefinition
Nasal file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
04250407736507FENTEX441918FX441918FX2022-12-12
04250407736514FENTEX441920FX441920FX2022-12-12
04250407736538FENTEX442014FX442014FX2022-12-12
04250407736545FENTEX442018FX442018FX2022-12-12
04250407736552FENTEX442020FX442020FX2022-12-12
04250407736576FENTEX442114FX442114FX2022-12-12
04250407736590FENTEX442118FX442118FX2022-12-12
04250407736606FENTEX442120FX442120FX2022-12-12
04250407736637FENTEX442214FX442214FX2022-12-12
04250407736644FENTEX442218FX442218FX2022-12-12
04250407736651FENTEX442220FX442220FX2022-12-12
04250407736675FENTEX442314FX442314FX2022-12-12
04250407736682FENTEX442318FX442318FX2022-12-12
04250407736699FENTEX442320FX442320FX2022-12-12
04250407736712FENTEX442414FX442414FX2022-12-12
04250407736729FENTEX442418FX442418FX2022-12-12
04250407736736FENTEX442420FX442420FX2022-12-12
04250407736750FENTEX442514FX442514FX2022-12-12
04250407736767FENTEX442518FX442518FX2022-12-12
04250407736774FENTEX442520FX442520FX2022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776432270MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776431440MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776432140MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776428020MillenniumAvalign Technologies, Inc.LRC2026-08-27
00190776428174MillenniumAvalign Technologies, Inc.LRC2026-08-27
00844505014762BONE WAX APPLICATORGrace Medical, Inc.LRC2026-08-27
00190776427566MillenniumAvalign Technologies, Inc.LRC2026-08-26
04054462913633evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913732evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913763evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913794evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913824evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913831evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913855evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913893evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914005evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914012evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914036evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914067evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914074evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914081evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914098evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914104evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914111evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914142evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914203evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914234evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914241evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914258evonosevonos GmbH & Co. KGLRC2026-08-25