AccessGUDID - DEVICE: CoolSmooth PRO Applicator (00816417020278)

GUDID

Device Identifier (DI) Information

Brand Name: CoolSmooth PRO Applicator
Version or Model: BRZ-AP1-091-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRZ-AP1-091-001
Company Name: Zeltiq Aesthetics, Inc.

Primary DI Number: 00816417020278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809152916 *Terms of Use

Device Description: CoolSmooth PRO Applicator

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?
56309	Cryolipolysis body contouring system applicator	A component of a cryolipolysis body contouring system designed to convey controlled cold from the system's control unit to the skin and subcutaneous tissues for cold-assisted lipolysis (coolsculpting). It is typically in the form of an articulated arm designed to hold a gel pad against the surface of the treatment site, and may also be used to apply vacuum to facilitate the treatment; optional pulsatile massage may also be applied. This is a reusable 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: 93bdae0c-3711-4840-adf8-b2ecaf2434ce
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016