FDA.reportPublic FDA data

Audion

Primary DI
00850002250428
Brand
Audion
Company
STRYKER CORPORATION
Model
AET-100
Device description
ET dilation system
Published
2022-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PNZEustachian Tube Balloon Dilation Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNZEustachian Tube Balloon Dilation DeviceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002250428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002250428008500022504288500022504280850002250428

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, single-useA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown through the device and into the middle ear. It is typically made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260759931680VenSure 4D Balloon Dilation SystemFiagon GmbHPNZ2025-09-18
04250676745088TubaVent® balloon dilatation systemSpiggle & Theis Medizintechnik GmbHPNZ2025-02-27
04250676743473Inflation deviceSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743503TubaVent® shortSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743510TubaVent® short wideSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743527TubaInsert® - Type 45°Spiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04260759931246VenSure Balloon Dilation SystemFiagon GmbHPNZ2022-11-10
04260759931260VenSure Nav Balloon Dilation SystemFiagon GmbHPNZ2022-11-10
04260759931253VenSure Light Balloon Dilation SystemFiagon GmbHPNZ2022-10-14
00763000416034NuVentMEDTRONIC XOMED, INC.PNZ2021-10-04
10705031465565ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
10705031465572ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
10705031465596ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465579ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465586ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465609ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465616ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
00857326005000XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005017XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005024XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005031XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005048XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005055XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005062XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005079XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005116XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005123XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005130XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005147XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
10705031230880ACCLARENT AERAACCLARENT, INC.PNZ2016-11-17