FDA.reportPublic FDA data

Solo+ TTD Cartridge

Primary DI
05391528890101
Brand
Solo+ TTD Cartridge
Company
AVENTAMED DESIGNATED ACTIVITY COMPANY
Model
12115-200-000
Catalog number
12115-200-000
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
MR Conditional
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
05391528890132PackageGS110In Commercial Distribution
05391528890149PackageGS19In Commercial Distribution
05391528890200PackageGS16In Commercial Distribution
05391528890217PackageGS13In Commercial Distribution
05391528890101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391528890132053915288901325391528890132
05391528890149053915288901495391528890149
05391528890200053915288902005391528890200
05391528890217053915288902175391528890217
05391528890101053915288901015391528890101

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter1.14Millimeter

Sterilization Methods#

Method table
Method

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391528890156Solo+ TTD Handpiece12115-100-00012115-100-0002024-07-19
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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