ClearUP Sinus Relief Pain

FDA UDI

Class II (US FDA UDI)

by Tivic Health Systems, Inc.

Identity

Trade Name: ClearUP Sinus Relief Pain FDA UDI
Generic Name: Craniofacial analgesia electrical stimulator FDA UDI
Model / Reference: SN100 FDA UDI

Identifiers

Catalog Number: SN100 FDA UDI
Primary DI / UDI-DI: 00850006251001 FDA UDI
FDA Product Code: GZJ FDA UDI
QNU FDA UDI
GMDN Term: Craniofacial analgesia electrical stimulator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5890 FDA UDI
874.6000 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

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: Craniofacial analgesia electrical stimulator

ClearUP Sinus Relief Pain by Tivic Health Systems, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Tivic Health Systems, Inc.

Sources (1)

FDA UDI 68878fa3-6b2a-4f76-91b0-21d171a1001c 33 fields · synced May 30, 2026