Catalog Number

CS-CS-D01-04-00

Brand Name

CoolSculpting Elite Card, NFS, Direct, USA, CAN Solo 4 Tx

Version/Model Number

CS-CS-D01-04-00

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

e29d1866-11ed-48c1-8145-7b1d6c9ac281

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-