Loupe and Combo Case Name Plate

FDA UDI

Class I (US FDA UDI)

by Quality Aspirators, Inc.

Identity

Trade Name: Loupe and Combo Case Name Plate FDA UDI
Generic Name: Head-worn lamp FDA UDI
Device Name: Loupe and Combo Case Name Plate FDA UDI
Model / Reference: Loupe and Combo Case Name Plate FDA UDI
Description: Loupe and Combo Case Name Plate FDA UDI

Identifiers

Catalog Number: 308-10097 FDA UDI
Primary DI / UDI-DI: 00814005024806 FDA UDI
FDA Product Code: HJH FDA UDI
GMDN Term: Head-worn lamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.5120 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Head-worn lamp

Loupe and Combo Case Name Plate by Quality Aspirators, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Head-worn lamp.

Quasar — ENOVA ILLUMINATION, INC · Class I
Quantum — ENOVA ILLUMINATION, INC · Class I
Amimon — Amimon Inc. · Class I
BR Surgical, LLC — BR SURGICAL LLC · Class I
MedLED Chrome — RIVERPOINT MEDICAL LLC · Class I
Quasar — ENOVA ILLUMINATION, INC · Class I
IsoLED II LED HL (AC) — Medical Illumination International, Inc · Class II
MedLED — RIVERPOINT MEDICAL LLC · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Quality Aspirators, Inc.

Sources (1)

FDA UDI ca4d753f-5142-4079-b2b3-697412e3dd2d 34 fields · synced May 30, 2026