New Direction

FDA UDI

Class I (US FDA UDI)

by Colors In Optics Ltd.

Identity

Trade Name: New Direction FDA UDI
Generic Name: Tinted non-prescription spectacles FDA UDI
Device Name: Sunglasses FDA UDI
Model / Reference: NEW DIRECTION ND103 - ROSEGOLD/WHITE FDA UDI
Description: Sunglasses FDA UDI

Identifiers

Catalog Number: ND103 RGDWH FDA UDI
Primary DI / UDI-DI: 00781268798716 FDA UDI
FDA Product Code: HQY FDA UDI
GMDN Term: Tinted non-prescription spectacles FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.5850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Tinted non-prescription spectacles

New Direction by Colors In Optics Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tinted non-prescription spectacles.

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GARGOYLES — FGX INTERNATIONAL INC. · Class I
Sunglasses — Taizhou YuanMing Glasses Co., Ltd · Class I
TAVAT Eyewear — TAVAT EYEWEAR SRL · Class I
FOSTER GRANT — FGX INTERNATIONAL INC. · Class I
HENRY SHEIN — FGX INTERNATIONAL INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Colors In Optics Ltd.

Sources (1)

FDA UDI 8ab578db-61a4-4b4c-a60e-075beec0b672 35 fields · synced Jun 1, 2026