Neozoline Ventilation Tubes
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- NeoZoline EUDAMEDRosen Inserter FDA UDI
- Generic Name
- Tympanostomy tube inserter, single-use FDA UDI
- Device Name
- Rosen Inserter EUDAMED
- Model / Reference
- NZ3461-100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421901970895 EUDAMEDFDA UDI
- Basic UDI-DI
- 942190197NZ3461-10079 EUDAMED
- Direct Marketing DI
- 09421901970895 EUDAMED
- 510(k) Number
- K061058 FDA 510(k)
- FDA Product Code
- ETD FDA 510(k)JYH FDA UDI
- EMDN Code
- Q030306 ENT SURGERY CURETTES, SINGLE-USE EUDAMED
- GMDN Term
- Tympanostomy tube inserter, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3880 FDA 510(k)
- Regulation Number
- 874.3880 FDA 510(k)874.4420 FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Neozoline Ventilation Tubes are classified as tympanostomy tubes, designed for the surgical placement in the tympanic membrane to maintain middle ear aeration and drainage of fluid in conditions such as chronic otitis media with effusion. These tubes facilitate ventilation of the middle ear, reducing pressure and preventing recurrent infections by allowing fluid to escape while permitting airflow.
These tubes are supplied sterile and intended for single-use. They are classified under FDA device class II and comply with the MDR (Medical Device Regulation). Available in multiple sizes and reference codes (e.g., 3013557562, 1045254), they are regulated under the product code ETD and are intended for use in otolaryngological procedures. Storage and handling must adhere to sterile medical device protocols to ensure safety and efficacy.
Frequently asked questions
What clinical conditions are the Neozoline Ventilation Tubes specifically designed to address in patients?
The Neozoline Ventilation Tubes are designed for surgical placement in the tympanic membrane to manage conditions like chronic otitis media with effusion. They help maintain middle ear aeration and drainage of fluid, reducing pressure and preventing recurrent infections by allowing fluid to escape while permitting airflow.
Are the Neozoline Ventilation Tubes intended for reuse, or are they single-use only?
The Neozoline Ventilation Tubes are explicitly intended for single-use only, as stated in the manufacturer’s specifications. This ensures sterility and safety for each patient procedure.
How should the Neozoline Ventilation Tubes be stored to maintain their sterility and integrity?
The tubes must be stored and handled according to sterile medical device protocols, as required for all sterile products. This includes keeping them in their original packaging until ready for use and avoiding contamination or exposure to environmental conditions that could compromise sterility.
What regulatory pathways have been followed for the Neozoline Ventilation Tubes, and which advisory committee was involved?
The Neozoline Ventilation Tubes have undergone FDA 510(k) clearance and comply with the Medical Device Regulation (MDR). The submission was reviewed by the Ear, Nose, and Throat (EN) advisory committee, which specializes in otolaryngological devices, as indicated by the product code (ETD) and advisory committee description.
What range of sizes or reference codes are available for the Neozoline Ventilation Tubes?
The Neozoline Ventilation Tubes are available in multiple sizes, each identified by unique reference codes such as 3013557562, 1045254, and others listed in the specifications. These codes correspond to different tube dimensions to accommodate varying patient needs in otolaryngological procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K061058 | Class II | Active |
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Manufacturer
- Manufacturer
- Adept Medical Ltd
- FDA Applicant
- Adept Medical, Ltd.
Sources (3)
- FDA 510(k) K061058 24 fields · synced Sep 18, 2026
- FDA UDI 82e63b06-889d-4400-b7a3-ac1262627755 32 fields · synced May 30, 2026
- EUDAMED e6958ba1-27f0-4ce6-85ba-68f35c2bba22 61 fields · synced Jul 9, 2026