NeoGlo®

FDA UDI

Class I (US FDA UDI)

by Neotech Products LLC

Identity

Trade Name: NeoGlo® FDA UDI
Generic Name: Visible-light skin transilluminator FDA UDI
Device Name: The NeoGlo Transilluminator is a hand-held, battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients. FDA UDI
Model / Reference: Blue FDA UDI
Description: The NeoGlo Transilluminator is a hand-held, battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients. FDA UDI

Identifiers

Catalog Number: N555BL FDA UDI
Primary DI / UDI-DI: 00812594012594 FDA UDI
FDA Product Code: HJN FDA UDI
GMDN Term: Visible-light skin transilluminator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1945 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Visible-light skin transilluminator

NeoGlo® by Neotech Products 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: Neotech Products LLC

Sources (1)

FDA UDI b7d66be3-3878-40fe-9c0a-14a586a39c53 34 fields · synced Jun 6, 2026