AccessGUDID - DEVICE: Currentbody Skin Neck & Dec Perfector (05060534510142)

GUDID

Device Identifier (DI) Information

Brand Name: Currentbody Skin Neck & Dec Perfector
Version or Model: TN2037
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 112A
Company Name: I-SMART DEVELOPMENTS LIMITED

Primary DI Number: 05060534510142
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 223616320 *Terms of Use

Device Description: Décolletage & Neck Device- Currentbody Skin Branded

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?
47704	Cosmetic red-light phototherapy system, home-use	An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

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
Storage Environment Temperature: between -5 and 55 Degrees Celsius
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 79bb0c80-f9e3-4d47-aa15-37f39992075e
Public Version Date: September 04, 2023
Public Version Number: 2
DI Record Publish Date: May 05, 2021