AccessGUDID - DEVICE: CoolAdvantage Plus, Gasket (00816417020803)

GUDID

Device Identifier (DI) Information

Brand Name: CoolAdvantage Plus, Gasket
Version or Model: BRZ-LN1-180-016
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRZ-LN1-180-016
Company Name: Zeltiq Aesthetics, Inc.

Primary DI Number: 00816417020803
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 16
Labeler D-U-N-S® Number*: 809152916 *Terms of Use

Device Description: Kit, 16-Pack, Gasket, Contour, CoolAdvantage Plus

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?
62441	Cryolipolysis body contouring system	An assembly of devices designed to non-invasively apply cold to the skin and subcutaneous tissues for subcutaneous fat layer reduction through cold-assisted lipolysis (coolsculpting); it may additionally be used to provide local anaesthesia for procedures that produce minor discomfort. It primarily consists of a mains electricity (AC-powered) control unit to produce the thermal energy, and an applicator and gel pad to convey the thermal energy to the target area (e.g., chin, hips, abdomen, thighs); additional components may be included (e.g., disposable liner for the applicator, electronic program cards, pager).	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: ca022282-c89d-4361-80c6-704390db9cc0
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 07, 2016