FDA.reportPublic FDA data

TubaVent® short

Primary DI
04250676743503
Brand
TubaVent® short
Company
Spiggle & Theis Medizintechnik GmbH
Model
2080-1236320-US
Catalog number
2080-1236320-US
Published
2023-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223542000TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH2023-08-03PNZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676743503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676743503042506767435034250676743503

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250676750662Farrior ear speculumM1018601M10186012026-10-28
04250676750679Farrior ear speculumM1018602M10186022026-10-28
04250676750686Farrior ear speculumM1018604M10186042026-10-28
04250676750693Farrior ear speculumM1018603M10186032026-10-28
04250676750709Farrior ear speculumM1018605M10186052026-10-28
04250676750716Farrior ear speculumM1018606M10186062026-10-28
04250676750723Farrior ear speculumM1018607M10186072026-10-28
04250676750730Farrior ear speculumM1018608M10186082026-10-28
04250676750761Hartmann ear speculumM1020000M10200002026-10-28
04250676750778Hartmann ear speculumM1020001M10200012026-10-28
04250676750785Hartmann ear speculumM1020002M10200022026-10-28
04250676750792Hartmann ear speculumM1020003M10200032026-10-28
04250676750808Hartmann ear speculumM1020004M10200042026-10-28
04250676750815Lucae cerumen hookM1025001M10250012026-10-28
04250676750822Lucae cerumen hookM1025002M10250022026-10-28
04250676750839Lucae cerumen hookM1025003M10250032026-10-28
04250676750846Buck ear curetteM1026001M10260012026-10-28
04250676750853Buck ear curetteM1026002M10260022026-10-28
04250676750860Buck ear curetteM1026003M10260032026-10-28
04250676750877Buck ear curetteM1026010M10260102026-10-28

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
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
00850002250428Audion STRYKER CORPORATIONPNZ2022-06-03
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