AccessGUDID - DEVICE: Hydrafacial Syndeo (00810007533711)

GUDID

Device Identifier (DI) Information

Brand Name: Hydrafacial Syndeo
Version or Model: 120V Black, Non Medical
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7000078-BLK-NMD
Company Name: Hydrafacial LLC

Primary DI Number: 00810007533711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364134791 *Terms of Use

Device Description: 100 –120VAC, 50/60Hz, 2A

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):	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?
11177	Skin abrasion unit	A mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This GMDN code may reflect old technology.	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: 585dd60f-c5eb-48fc-af85-81410decccf6
Public Version Date: July 26, 2024
Public Version Number: 1
DI Record Publish Date: July 18, 2024