DEVICE: CoolAdvantage Petite Card (00081641702102)
Device Identifier (DI) Information
CoolAdvantage Petite Card
BRZ-CD4-140-003
Not in Commercial Distribution
BRZ-CD4-140-003
Zeltiq Aesthetics, Inc.
BRZ-CD4-140-003
Not in Commercial Distribution
BRZ-CD4-140-003
Zeltiq Aesthetics, Inc.
CoolAdvantage Petite Card, CD4, Direct, 3 Cycles
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
56312 | Cryolipolysis body contouring system program card |
A portable electronic device designed to connect to the data port of a cryolipolysis body contouring system to provide its control unit with a selected treatment profile. It contains data such as cooling intensity factor (CIF), cycle time and other relevant treatment data, and is factory programmed so that the data cannot be modified. It is made of metal and plastic materials and has a connector at one end to connect to computerized devices. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OOK | Dermal Cooling Pack/Vacuum/Massager |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fdda4d69-fbbd-4391-9dda-1e70febfdf31
January 30, 2020
3
January 31, 2017
January 30, 2020
3
January 31, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
888-935-8471
support@zeltiq.com
support@zeltiq.com