AccessGUDID - DEVICE: CoolLiner Max (10816417020725)

GUDID

Device Identifier (DI) Information

Brand Name: CoolLiner Max
Version or Model: BRZ-LN1-08X-008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRZ-LN1-08X-008
Company Name: Zeltiq Aesthetics, Inc.

Primary DI Number: 10816417020725
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 809152916 *Terms of Use

Device Description: CoolLiner Max, Qty 8

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:	Yes
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?
56310	Cryolipolysis body contouring system applicator liner	A non-sterile cover designed to provide a hygienic barrier between the contact surface of a cryolipolysis body contouring system applicator and a dedicated gel pad placed on the surface of a patient's skin during cold-assisted lipolysis treatment (coolsculpting). It is typically made of disposable plastic material (e.g., a thin plastic) and may be shaped to fit the applicator head. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	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: 36d12f82-955b-4196-a3e5-49d321ce88c6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016