AccessGUDID - DEVICE: Perfectio + (00850001456012)

GUDID

Device Identifier (DI) Information

Brand Name: Perfectio +
Version or Model: P900B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Omm Imports Inc.

Primary DI Number: 00850001456012
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2031
Device Count: 1
Labeler D-U-N-S® Number*: 010000704 *Terms of Use

Device Description: Over the counter red and infrared phototherapy device for the treatment of wrinkles.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
62202	Blue/red/infrared phototherapy lamp	A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHS	Light Based Over The Counter Wrinkle Reduction

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: f4ab3320-fc31-4652-bc7d-1c3d1faf3e5f
Public Version Date: July 04, 2022
Public Version Number: 1
DI Record Publish Date: June 24, 2022