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Phoenix ICON GO

FDA UDI

Class II (US FDA UDI)

by Phoenix Clinical

Identity

Trade Name
Phoenix ICON GO FDA UDI
Generic Name
Ophthalmic fundus camera FDA UDI
Device Name
The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, cornea, and external structures of the eye. FDA UDI
Model / Reference
PCI 40-2001 FDA UDI
Description
The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, cornea, and external structures of the eye. FDA UDI

Identifiers

Primary DI / UDI-DI
00857253006088 FDA UDI
FDA Product Code
PJZ FDA UDI
GMDN Term
Ophthalmic fundus camera FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ophthalmic fundus camera

Phoenix ICON GO by Phoenix Clinical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic fundus camera.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phoenix Clinical

Sources (1)

  • FDA UDI b7d628b1-e9ce-4b9b-be7c-99502dac3f5e 34 fields · synced May 30, 2026