AccessGUDID - DEVICE: Sion Surgical Instrument (00858027006501)

GUDID

Device Identifier (DI) Information

Brand Name: Sion Surgical Instrument
Version or Model: FG 08255
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1-107
Company Name: Sight Sciences, Inc.

Primary DI Number: 00858027006501
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962750381 *Terms of Use

Device Description: The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument.

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?
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
HMZ	Trabeculotome

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: 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: d6cb0d0c-d3e6-4984-b50c-a0f379bee993
Public Version Date: August 22, 2023
Public Version Number: 2
DI Record Publish Date: August 01, 2022