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
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

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