CoolSculpting Securement Strap Extra Large

FDA UDI

Class II (US FDA UDI)

by Zeltiq Aesthetics, Inc.

Identity

Trade Name: CoolSculpting Securement Strap Extra Large FDA UDI
Generic Name: Cryolipolysis skin/body contouring system FDA UDI
Device Name: CoolSculpting Securement Strap Extra Large FDA UDI
Model / Reference: CS-SS-XL-02-00 FDA UDI
Description: CoolSculpting Securement Strap Extra Large FDA UDI

Identifiers

Primary DI / UDI-DI: 00816417021633 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

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Cryolipolysis skin/body contouring system

CoolSculpting Securement Strap Extra Large 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.

CoolMini Securement Straps — Zeltiq Aesthetics, Inc. · Class II
Foam Borders, S150 Applicator — 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
Pre-Treatment Skin Wipe — 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 00c7241d-fc23-46d7-9cc7-2d5c3884bf45 34 fields · synced Jun 8, 2026