AccessGUDID - DEVICE: Cellfina Motor Module Device and Package (00840763100384)

GUDID

Device Identifier (DI) Information

Brand Name: Cellfina Motor Module Device and Package
Version or Model: CM1 Rev C, D, E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ulthera, Inc.

Primary DI Number: 00840763100384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010981554 *Terms of Use

Device Description: No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI

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?
62247	Mechanical skin contouring system motor	A non-sterile, mains electricity (AC-powered) motor component of a mechanical skin contouring system intended to temporarily minimize the manifestation of cellulite by transection of the cellulite-tethering fibrous tissue by motorized mechanical means. It is used to create a rotational force that is applied to a sharp cutting tool, and is held in place by template plates (not included) that also guide the cutting instrument.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

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: aaa4d431-3f96-4d7f-9275-1f057e9a18f3
Public Version Date: May 09, 2024
Public Version Number: 3
DI Record Publish Date: September 07, 2016