AccessGUDID - DEVICE: LAMEVEN Eye Massager (06975977230016)

GUDID

Device Identifier (DI) Information

Brand Name: LAMEVEN Eye Massager
Version or Model: MD-206
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dongguan City Umed Technology Co., Ltd

Primary DI Number: 06975977230016
Issuing Agency: GS1
Commercial Distribution End Date: January 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 602090959 *Terms of Use

Device Description: No description.

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?
64742	Eyelid massager	An electrically-powered ophthalmic device intended to control the application of rotary (oscillating) massage to an eyelid during treatment of lid margin disease (LMD), meibomian gland dysfunction (MGD) and/or evaporative dry eye. It is a hand-held unit used with disposable tips (not included) intended for eyelid contact; it is intended to be used in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

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: c370538a-d752-4079-b99a-e90de0466224
Public Version Date: January 02, 2023
Public Version Number: 2
DI Record Publish Date: December 20, 2022