AccessGUDID - DEVICE: sensiFirm (05060445341118)

GUDID

Device Identifier (DI) Information

Brand Name: sensiFirm
Version or Model: CEL100US01SNS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EL GLOBAL TRADE LTD

Primary DI Number: 05060445341118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649726981 *Terms of Use

Device Description: The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite

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?
58454	Radio-frequency skin surface treatment system	An assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin’s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
PBX	Massager, Vacuum, Radio Frequency Induced Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170637	000

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: 61606518-757b-481f-9b36-6ea176fe3a8a
Public Version Date: February 07, 2020
Public Version Number: 4
DI Record Publish Date: August 16, 2017