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Optego

FDA UDI

Class I (US FDA UDI)

by Optego Vision USA, Inc.

Identity

Trade Name
Optego FDA UDI
Generic Name
Vision testing/training flipper FDA UDI
Device Name
OEP Chairside Diagnostic Set +/-0.25 red handle +/-0.50 orange handle +0.50/+0.75 yellow handle +1.00/+1.25 green handle +1.50/+1.75 blue handle +/-2.00 violet handle flipper base FDA UDI
Model / Reference
93451 FDA UDI
Description
OEP Chairside Diagnostic Set +/-0.25 red handle +/-0.50 orange handle +0.50/+0.75 yellow handle +1.00/+1.25 green handle +1.50/+1.75 blue handle +/-2.00 violet handle flipper base FDA UDI

Identifiers

Primary DI / UDI-DI
00360843007445 FDA UDI
FDA Product Code
HPC FDA UDI
GMDN Term
Vision testing/training flipper FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1405 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vision testing/training flipper

Optego by Optego Vision USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vision testing/training flipper.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Optego Vision USA, Inc.

Sources (1)

  • FDA UDI 2d34bba8-9b88-4a15-b746-f5af0c2ec36b 33 fields · synced May 31, 2026