Nike

FDA UDI

Class I (US FDA UDI)

by Burlington Medical, Llc

Identity

Trade Name: Nike FDA UDI
Generic Name: Radiation shielding goggles/spectacles FDA UDI
Device Name: CITY ICON GLASSES, SINGLE VISION, .75MM PB EQ FDA UDI
Model / Reference: EW-0022-SV FDA UDI
Description: CITY ICON GLASSES, SINGLE VISION, .75MM PB EQ FDA UDI

Identifiers

Primary DI / UDI-DI: 00840331297126 FDA UDI
FDA Product Code: IWS FDA UDI
GMDN Term: Radiation shielding goggles/spectacles FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.6500 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: Radiation shielding goggles/spectacles

Nike by Burlington Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Burlington Medical, Llc

Sources (1)

FDA UDI eed6d721-c203-411b-ba87-2a718f1bce9b 33 fields · synced May 30, 2026