Freeze Away Wart Remover

FDA UDI

Class II (US FDA UDI)

by Scholl's Wellness Company

Identity

Trade Name: Freeze Away Wart Remover FDA UDI
Generic Name: Wart-removal cryogenic kit FDA UDI
Device Name: Cryogenic wart remover FDA UDI
Model / Reference: 90000335 FDA UDI
Description: Cryogenic wart remover FDA UDI

Identifiers

Primary DI / UDI-DI: 20888853000101 FDA UDI
510(k) Number: K031697 FDA UDI
FDA Product Code: GEH FDA UDI
GMDN Term: Wart-removal cryogenic kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4350 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wart-removal cryogenic kit

Freeze Away Wart Remover by Scholl's Wellness Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Up&Up — TARGET CORPORATION · Class II
H.E.B Wart Freezer — H. E. BUTT GROCERY COMPANY · Class II

Cleared under the same submission

K031697 also covers:

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: Scholl's Wellness Company

Sources (1)

FDA UDI 5bb596a0-2ef4-42c8-b93e-e23383de115a 36 fields · synced Jun 6, 2026