AccessGUDID - DEVICE: FSYX Ocular Pressure Adjusting Pump (00860012858408)

GUDID

Device Identifier (DI) Information

Brand Name: FSYX Ocular Pressure Adjusting Pump
Version or Model: 400-6008-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Balance Ophthalmics Inc.

Primary DI Number: 00860012858408
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119381400 *Terms of Use

Device Description: The FSYX OPAP connects to the OPAP Goggles through tubing to create the vacuum inside the Goggles.

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):	Yes
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?
67474	Intraocular pressure-reducing vacuum system pump	An electrically-powered, portable component of an intraocular pressure-reducing vacuum system designed for use by a healthcare professional to create and control negative pressure around the eye for the noninvasive, bilateral reduction of intraocular pressure (IOP) for the treatment of open-angle glaucoma. It is in the form of a small unit with connection points for suction and sensing tubing which are attached to the lenses of intraocular pressure-reducing vacuum system goggles (not included). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QQJ	Applicator, Negative Pressure, External, Ocular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230055	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: 03180a42-9362-45b0-ad34-7d8817389440
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025