AccessGUDID - DEVICE: CoolSculpting Upper Module (00816417020018)

GUDID

Device Identifier (DI) Information

Brand Name: CoolSculpting Upper Module
Version or Model: BRZ-CG1-UMD-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRZ-CG1-UMD-000
Company Name: Zeltiq Aesthetics, Inc.

Primary DI Number: 00816417020018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809152916 *Terms of Use

Device Description: Control Unit

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56308	Cryolipolysis body contouring system control unit	A mains electricity (AC-powered) component of a cryolipolysis body contouring system designed to allow the operator to adjust and control the operating functions of the system during cold-assisted lipolysis treatment (coolsculpting) to regulate the cooling modes, create the applied vacuum, and monitor the procedure. An applicator that delivers the thermal energy to the body is connected to this device.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6fa71e1-53a8-4224-b1d4-1f69717f9d28
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016