AccessGUDID - DEVICE: Zaffiro IR Treatment Applicator (00850017374065)

GUDID

Device Identifier (DI) Information

Brand Name: Zaffiro IR Treatment Applicator
Version or Model: ZIR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300-1104
Company Name: NEAUVIA NORTH AMERICA, INC.

Primary DI Number: 00850017374065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117030786 *Terms of Use

Device Description: Applicator to perform a non-invasive, thermo-lifting with the Zaffiro System

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):	No
Over the Counter (OTC):	Yes
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?
32388	Dermabrasion brush, rotary	A device with wire bristles that is rotated in a power-driven tool to plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFE	Brush, Dermabrasion, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 0ae2ba00-ca62-45f7-8781-4f1abcecaf3e
Public Version Date: May 13, 2021
Public Version Number: 2
DI Record Publish Date: September 14, 2020