FDA.reportPublic FDA data

Solo+ TTD Handpiece

Primary DI
05391528890156
Brand
Solo+ TTD Handpiece
Company
AVENTAMED DESIGNATED ACTIVITY COMPANY
Model
12115-100-000
Catalog number
12115-100-000
Device description
The Solo+ TTD is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.
Published
2024-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETDTube, Tympanostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETDTube, TympanostomyEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232702000Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac2024-05-20ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391528890163PackageGS14In Commercial Distribution
05391528890170PackageGS19In Commercial Distribution
05391528890187PackageGS16In Commercial Distribution
05391528890194PackageGS13In Commercial Distribution
05391528890156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391528890163053915288901635391528890163
05391528890170053915288901705391528890170
05391528890187053915288901875391528890187
05391528890194053915288901945391528890194
05391528890156053915288901565391528890156

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tubeA small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

Contacts#

Phone, Email table
PhoneEmail
+353214928980john.vaughan@karlstorz.com

Regulatory Flags#

DUNS number
985579745
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391528890101Solo+ TTD Cartridge12115-200-00012115-200-0002024-07-19
05391528890163Solo+ TTD Handpiece12115-100-00012115-100-0002024-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6333816500JEDMEDJEDMED INSTRUMENT COMPANYETD2023-05-08
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00385640068659Summit MedicalSummit Medical, Inc.ETD2022-10-06
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