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CoolAdvantage Card

FDA UDI

Class II (US FDA UDI)

by Zeltiq Aesthetics, Inc.

Identity

Trade Name
CoolAdvantage Card FDA UDI
Generic Name
Cryolipolysis body contouring system program card FDA UDI
Device Name
CoolAdvantage Card, CD4, Direct, 3 Cycle FDA UDI
Model / Reference
BRZ-CD4-160-003 FDA UDI
Description
CoolAdvantage Card, CD4, Direct, 3 Cycle FDA UDI

Identifiers

Catalog Number
BRZ-CD4-160-003 FDA UDI
Primary DI / UDI-DI
00816417020636 FDA UDI
FDA Product Code
OOK FDA UDI
GMDN Term
Cryolipolysis body contouring system program card 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cryolipolysis body contouring system program card

CoolAdvantage Card by Zeltiq Aesthetics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cryolipolysis body contouring system program card.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeltiq Aesthetics, Inc.

Sources (1)

  • FDA UDI ce9da6f4-6cf2-420c-9075-8ca7849392e5 35 fields · synced Jun 8, 2026