FDA.reportPublic FDA data

FENTEX

Primary DI
04250407705961
Brand
FENTEX
Company
FENTEX medical GmbH
Model
053800FX
Catalog number
053800FX
Device description
Handle for 054500FX - 054530FX
Published
2022-12-07
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
04250407705961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407705961042504077059614250407705961

GMDN Terms#

Term, Definition table
TermDefinition
Rhinoscopic mirrorA hand-held surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end used for a rhinoscopic examination. The mirror is affixed to a very long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the nose. 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
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
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
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04250676750822Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750839Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750891Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750907Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750914Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750921Snellen ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750938Snellen ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
B382SD67371410Surgical DirectSurgical Direct, Inc.LRC2026-10-28
B382SD9114681000Surgical DirectSurgical Direct, Inc.LRC2026-10-28
00190776423070MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435813MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435820MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435837MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435844MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435851MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435868MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436735MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436742MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436759MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435417MillenniumAvalign Technologies, Inc.LRC2026-10-19
00190776434946MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434977MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434618MillenniumAvalign Technologies, Inc.LRC2026-10-09
00198506095795ELMED INCORPORATEDELMED INCORPORATEDLRC2026-10-09
00190776433529MillenniumAvalign Technologies, Inc.LRC2026-10-06
00192896123854Gum ScissorsSONTEC INSTRUMENTS, INC.LRC2026-10-06
00190776433093MillenniumAvalign Technologies, Inc.LRC2026-10-01
00190776432539MillenniumAvalign Technologies, Inc.LRC2026-09-28
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24