FDA.reportPublic FDA data

FENTEX

Primary DI
04250407704803
Brand
FENTEX
Company
FENTEX medical GmbH
Model
042700FX
Catalog number
042700FX
Device description
Light Carrier for 042740FX - 042790FX Ø 3 mm
Published
2022-12-07
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
EPYSPECULUM, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250407704803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407704803042504077048034250407704803

GMDN Terms#

Term, Definition table
TermDefinition
ENT transilluminatorA hand-held instrument intended to be used to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination. It is connected through a light cable, that may or may not be part of the device, to a light source that generates the light. Its exterior is typically made of high-grade stainless steel; it has a fibreoptic bundle core that conducts the light to the target site. 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
B382SD9210921080Surgical DirectSurgical Direct, Inc.EPY2026-10-20
00190776435165MillenniumAvalign Technologies, Inc.EPY2026-10-16
00190776435172MillenniumAvalign Technologies, Inc.EPY2026-10-16
00724995267391Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267407Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267414Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267421Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267445Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267452Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267469Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267476Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
G141546073500Carnegie Surgical LLCCarnegie Surgical LLCEPY2026-09-30
D955SPCM1Paul BandittTerlain Enterprises, Inc.EPY2026-09-25
00190776432256MillenniumAvalign Technologies, Inc.EPY2026-09-24
00810238290094PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290100PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290117PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290124PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
04054462156481evonosevonos GmbH & Co. KGEPY2026-08-26
04054462902286evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902293evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902309evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902316evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902330evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902385evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902408evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902415evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902422evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902439evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902446evonosevonos GmbH & Co. KGEPY2026-08-21