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Vestibular First

FDA UDI

Class II (US FDA UDI)

by Vestibular First

Identity

Trade Name
Vestibular First FDA UDI
Generic Name
Eye/eyelid movement monitoring spectacles/goggles FDA UDI
Device Name
The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions. FDA UDI
Model / Reference
Insight Disposable Cushions - 40-Count FDA UDI
Description
The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions. FDA UDI

Identifiers

Catalog Number
PART-DISPOSABLE-CUSHION-40CT FDA UDI
Primary DI / UDI-DI
00860002280714 FDA UDI
510(k) Number
K203082 FDA UDI
FDA Product Code
GWN FDA UDI
GMDN Term
Eye/eyelid movement monitoring spectacles/goggles FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1460 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Eye/eyelid movement monitoring spectacles/goggles

Vestibular First by Vestibular First — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eye/eyelid movement monitoring spectacles/goggles.

Cleared under the same submission

K203082 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vestibular First

Sources (1)

  • FDA UDI 656bc10b-3dcd-48ee-a9b2-57ead46d1fe6 37 fields · synced May 30, 2026