Catalog Number

-

Brand Name

CoolSculpting Card, 100 Cycle

Version/Model Number

CS-303932

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

OOK

Product Code Name

Dermal Cooling Pack/Vacuum/Massager

Public Device Record Key

fa071f14-5eee-4a95-aa7c-981692949ae7

Public Version Date

November 13, 2019

Public Version Number

1

DI Record Publish Date

November 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-