Silverstein

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Silverstein FDA UDI
Generic Name: Tympanostomy tube FDA UDI
Device Name: VENT TUBE 1028065 5PK SPAT 1.14X12MM SIL FDA UDI
Model / Reference: 1028065 FDA UDI
Description: VENT TUBE 1028065 5PK SPAT 1.14X12MM SIL FDA UDI

Identifiers

Primary DI / UDI-DI: 00681490030038 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 12.0 Millimeter FDA UDI

Category: Tympanostomy tube

The Silverstein Tympanostomy Tube, a portable and disposable ventilator device for middle ear ventilation and drainage. Designed for bilateral use in pediatric and adult patients, this device is compliant with FDA 510(k) regulations and marketed as an OTC product.

Similar devices

Also classified as Tympanostomy tube.

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NeoZoline — ADEPT MEDICAL LIMITED · 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

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: Medtronic Xomed, Inc.

Sources (1)

FDA UDI fd802038-abbb-4d68-9eae-387ab1e69c17 35 fields · synced Jul 14, 2026