OMNI Edge Surgical System

GUDID 00858027006594

OMNI Edge Surgical System

Sight Sciences, Inc.

Ophthalmic needle, single-use
Primary Device ID00858027006594
NIH Device Record Keya9e83f1d-56be-4aed-95d4-8e00738674ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameOMNI Edge Surgical System
Version Model Number1-112
Company DUNS962750381
Company NameSight Sciences, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858027006594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRHPump, Infusion, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-14
Device Publish Date2025-03-06

Devices Manufactured by Sight Sciences, Inc.

00858027006594 - OMNI Edge Surgical System2025-03-14OMNI Edge Surgical System
00858027006594 - OMNI Edge Surgical System2025-03-14 OMNI Edge Surgical System
00858027006433 - OMNI Surgical System2023-10-25 OMNI Surgical System, 21 uL
00858027006389 - TearCare(R) Clearance Assistant PLUS2023-08-30 TearCare Clearance Assistant PLUS
00858027006280 - TearCare SmartLid 2023-08-22 Eyelid heat therapy system applicator
00858027006266 - TearCare(R) Clearance Assistant - Sterile2023-08-04 Forceps - Sterile
00858027006525 - OMNI Surgical System2022-08-30 OMNI Surgical System: Ergo series of revisions
00858027006501 - Sion Surgical Instrument2022-08-09 The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument.
00858027006457 - TearCare System - TearCare SmartHub Kit2022-03-11 TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter

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