FDA.reportPublic FDA data

FENTEX

Primary DI
04250407771546
Brand
FENTEX
Company
FENTEX medical GmbH
Model
156665FX
Catalog number
156665FX
Device description
Stapes Probe with angled shaft 16 cm, 4.5 mm
Published
2022-12-08
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
KAKPROBE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250407771546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250407771546042504077715464250407771546

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. 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
04250407712549FENTEX120202FX120202FX2022-12-08
04250407712556FENTEX120203FX120203FX2022-12-08
04250407712563FENTEX120204FX120204FX2022-12-08
04250407712570FENTEX120206FX120206FX2022-12-08
04250407712587FENTEX120208FX120208FX2022-12-08
04250407712594FENTEX120210FX120210FX2022-12-08
04250407713577FENTEX135100FX135100FX2022-12-08
04250407713584FENTEX135101FX135101FX2022-12-08
04250407713591FENTEX135102FX135102FX2022-12-08
04250407713607FENTEX135103FX135103FX2022-12-08
04250407714123FENTEX137101FX137101FX2022-12-08
04250407714130FENTEX137102FX137102FX2022-12-08
04250407714147FENTEX137103FX137103FX2022-12-08
04250407714192FENTEX142100FX142100FX2022-12-08
04250407714208FENTEX142101FX142101FX2022-12-08
04250407714215FENTEX142102FX142102FX2022-12-08
04250407714222FENTEX142103FX142103FX2022-12-08
04250407714314FENTEX142120FX142120FX2022-12-08
04250407714369FENTEX142130FX142130FX2022-12-08
04250407714581FENTEX143101FX143101FX2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275990Intrace USAPILOTIS TECH LLCKAK2026-07-03
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09348811005106INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-03-18
00714646001535Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
10714646001532Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
00714646001627Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
09348811115836INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-25
09348811112149INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
09348811150448INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
04250676728609Tube probeSpiggle & Theis Medizintechnik GmbHKAK2025-10-10
04250676731982Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676731999Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732002Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732026Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732033Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740625Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740632Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740649Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740656Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740663Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740687Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740694Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740700Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740717Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
00190776409487MillenniumAvalign Technologies, Inc.KAK2025-09-02
00757770407972Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00757770636334Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00194613044404MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613048952MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613059804MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01