AccessGUDID - DEVICE: Hello, eyes (08800024300009)

GUDID

Device Identifier (DI) Information

Brand Name: Hello, eyes
Version or Model: BIO Plug 0.4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bio Optics Co., Ltd

Primary DI Number: 08800024300009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690427205 *Terms of Use

Device Description: Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted into the lacrimal punctum gland to minimize the drainage of tears through the tear duct, thereby alleviating symptoms of dry eye.

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:	Yes
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?
36237	Lacrimal punctum plug	A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZU	Plug, Punctum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241229	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 46c23bc6-5697-495d-b9b9-82423826114a
Public Version Date: August 07, 2024
Public Version Number: 1
DI Record Publish Date: July 30, 2024