AccessGUDID - DEVICE: OMNI Surgical System (US) (00858027006334)

GUDID

Device Identifier (DI) Information

Brand Name: OMNI Surgical System (US)
Version or Model: FG 05757
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1-102
Company Name: Sight Sciences, Inc.

Primary DI Number: 00858027006334
Issuing Agency: GS1
Commercial Distribution End Date: October 28, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 962750381 *Terms of Use

Device Description: OMNI System for US in a single pack

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):	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?
47610	Ophthalmic needle, single-use	A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.	Active	false
62437	Trabeculotome, single-use	A hand-held manual ophthalmic surgical instrument intended to be used to perform a trabeculotomy, via transluminal access through Schlemm's canal (sinus venosus sclerae) and piercing of the trabecular meshwork, to reduce intraocular pressure (IOP) for the prevention/treatment of glaucoma. It is made of metal and plastic materials, and is in the form of a handle with a thin, flexible, extendable tip at the distal end designed to be progressively inserted into the eye through a corneal incision. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRH	Pump, Infusion, Ophthalmic
HMZ	Trabeculotome

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173332	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: f923d797-44c8-45ca-819e-eef6590c675c
Public Version Date: August 22, 2023
Public Version Number: 4
DI Record Publish Date: October 25, 2019