FDA.report

FENTEX

Primary DI
04250407709495
Brand
FENTEX
Company
FENTEX medical GmbH
Model
108103FX
Catalog number
108103FX
Device description
Raspatory by Lempert slightly curved 17 cm, width 4 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250407709495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250407709495042504077094954250407709495

GMDN Terms

TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
04250407788339FENTEX270263FX270263FX2025-12-30
04250407786847FENTEX540730FX540730FX2025-03-25
04250407786854FENTEX540732FX540732FX2025-03-25
04250407786861FENTEX540733FX540733FX2025-03-25
04250407786878FENTEX540734FX540734FX2025-03-25
04250407786885FENTEX540701FX540701FX2025-03-25
04250407786892FENTEX540702FX540702FX2025-03-25
04250407786908FENTEX540704FX540704FX2025-03-25
04250407778262FENTEX540780FX540780FX2025-02-19
04250407786663FENTEX118960FX118960FX2024-12-28
04250407786670FENTEX118970FX118970FX2024-12-28
04250407786731FENTEX540725FX540725FX2024-10-18
04250407786748FENTEX540726FX540726FX2024-10-18
04250407786755FENTEX540727FX540727FX2024-10-18
04250407786762FENTEX540728FX540728FX2024-10-18
04250407731571FENTEX363600FX363600FX2022-12-12
04250407731816FENTEX379100FX379100FX2022-12-12
04250407785116FENTEX540700FX540700FX2024-08-01
04250407785314FENTEX540705FX540705FX2024-08-01
04250407785321FENTEX540710FX540710FX2024-08-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417970MillenniumAvalign Technologies, Inc.LRC2026-03-23
00198506089756ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-23
00198506089657ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-17
00198506089534ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089541ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089558ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089572ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
08904461031073OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
08904428798377OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00198506088926ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-03
00190776417420MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417475MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417482MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417543MillenniumAvalign Technologies, Inc.LRC2026-02-27
00198506088865ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-25
00198506088469ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00198506088544ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00190776416546MillenniumAvalign Technologies, Inc.LRC2026-02-16
00190776415914MillenniumAvalign Technologies, Inc.LRC2026-02-06
00190776415778MillenniumAvalign Technologies, Inc.LRC2026-02-04
04059453133779Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-02-02
00198506088346ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-30
04059453133755Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-01-29
09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
00190776415495MillenniumAvalign Technologies, Inc.LRC2026-01-27
00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
00198506087813ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-16
00198506087899ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15
00198506087912ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15
00198506087929ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15