CoolCard Max - CoolCard Max - 8 Cycle - Zeltiq Aesthetics, Inc.

Duns Number:809152916

Device Description: CoolCard Max - 8 Cycle

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

BRZ-CD4-08X-008

Brand Name

CoolCard Max

Version/Model Number

BRZ-CD4-08X-008

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OOK

Product Code Name

Dermal Cooling Pack/Vacuum/Massager

Device Record Status

Public Device Record Key

e6e8e807-6cbf-4c7c-a475-1158a80a288e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZELTIQ AESTHETICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 129