NeoZoline

FDA UDI

Class II (US FDA UDI)

by Adept Medical Limited

Identity

Trade Name: NeoZoline FDA UDI
Generic Name: Tympanostomy tube FDA UDI
Device Name: Vent Tube Collar Button Tail - Double FDA UDI
Model / Reference: NZ3212-2 FDA UDI
Description: Vent Tube Collar Button Tail - Double FDA UDI

Identifiers

Catalog Number: NZ3212-2 FDA UDI
Primary DI / UDI-DI: 09421901970192 FDA UDI
510(k) Number: K061058 FDA UDI
FDA Product Code: ETD FDA UDI
GMDN Term: Tympanostomy tube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Tympanostomy tube

NeoZoline by Adept Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tympanostomy tube.

Sheehy — MEDTRONIC XOMED, INC. · Class II
SHEA PARASOL VENT TUBE W/TAB — Grace Medical, Inc. · Class II
DONALDSON VENT TUBE — Grace Medical, Inc. · Class II
NeoZoline — JEDMED Instrument Company · Class II
TINY TRIUNE VENT TUBE — Grace Medical, Inc. · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
TINY TRIUNE VENT TUBE — Grace Medical, Inc. · Class II
SHEPARD GROMMET VENT TUBE — Grace Medical, Inc. · Class II

Cleared under the same submission

K061058 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Adept Medical Limited

Sources (1)

FDA UDI 8fad408e-58a7-43bf-b2e2-086bc3eafa89 35 fields · synced May 30, 2026