Walgreens

FDA UDI

Class U (US FDA UDI)

by Walgreen Co.

Identity

Trade Name: Walgreens FDA UDI
Generic Name: Mouthguard, reusable FDA UDI
Device Name: Walgreens Dental Guard For Nighttime Teeth Grinding (Bruxism) 2 Dental Guards, 1 Storage Case, 1 Fitting Tray FDA UDI
Model / Reference: 630109 FDA UDI
Description: Walgreens Dental Guard For Nighttime Teeth Grinding (Bruxism) 2 Dental Guards, 1 Storage Case, 1 Fitting Tray FDA UDI

Identifiers

Catalog Number: SQN5494SB1 FDA UDI
Primary DI / UDI-DI: 00311917046877 FDA UDI
FDA Product Code: OBR FDA UDI
GMDN Term: Mouthguard, reusable FDA UDI

Classification

Device Class: U 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mouthguard, reusable

Walgreens by Walgreen Co. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mouthguard, reusable.

PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · Class II
Nylon Nightguard/Occlusal Appliance — SERENA SLEEP SOLUTIONS LLC · U
PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
AESCULAP — AESCULAP, 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 U	Pending data

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

Manufacturer

Manufacturer: Walgreen Co.

Sources (1)

FDA UDI c7e700ac-44d3-48dc-9e1b-c1c47c774232 35 fields · synced May 30, 2026