Pre-Treatment Skin Wipe

FDA UDI

Class II (US FDA UDI)

by Zeltiq Aesthetics, Inc.

Identity

Trade Name: Pre-Treatment Skin Wipe FDA UDI
Generic Name: Cryolipolysis skin/body contouring system FDA UDI
Device Name: Pre-Treatment Skin Wipe (10 count) package is the lowest level of marketed material. FDA UDI
Model / Reference: CS-CD-PSW-10-00 FDA UDI
Description: Pre-Treatment Skin Wipe (10 count) package is the lowest level of marketed material. FDA UDI

Identifiers

Primary DI / UDI-DI: 00816417021626 FDA UDI
FDA Product Code: OOK FDA UDI
GMDN Term: Cryolipolysis skin/body contouring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cryolipolysis skin/body contouring system

Pre-Treatment Skin Wipe by Zeltiq Aesthetics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cryolipolysis skin/body contouring system.

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Foam Borders, S150 Applicator — Zeltiq Aesthetics, Inc. · Class II
CoolSculpting Securement Strap Extra Large — Zeltiq Aesthetics, Inc. · Class II
CoolSculpting Securement Straps Extra Small — Zeltiq Aesthetics, Inc. · Class II
CoolSculpting Applicator Cable Support Arm — Zeltiq Aesthetics, Inc. · Class II
CoolSculpting Elite Securement Grip, S150 — Zeltiq Aesthetics, Inc. · Class II
CoolSculpting Quad Comfort Strap — Zeltiq Aesthetics, Inc. · Class II
Pretreatment Skin Wipes — Zeltiq Aesthetics, Inc. · Class II

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: Zeltiq Aesthetics, Inc.

Sources (1)

FDA UDI 24da9163-3dcf-46c5-a48b-2a5d110d5582 34 fields · synced Jun 6, 2026