OMNI PLUS

GUDID 00858027006358

OMNI PLUS Surgical System

SIGHT SCIENCES, INC.

Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use Ophthalmic needle, single-use
Primary Device ID00858027006358
NIH Device Record Key69eab465-93c5-4362-9aed-01cded0dc44a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOMNI PLUS
Version Model Number1-104
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
GS100858027006358 [Primary]
GS100858027006358 [Primary]
GS100858027006358 [Primary]
GS100858027006358 [Primary]
GS100858027006358 [Primary]
GS100858027006358 [Primary]
GS100858027006358 [Primary]
GS100858027006358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRHPump, Infusion, Ophthalmic
MRHPump, Infusion, Ophthalmic
MRHPump, Infusion, Ophthalmic
MRHPump, Infusion, Ophthalmic
MRHPump, Infusion, Ophthalmic
MRHPump, Infusion, Ophthalmic
MRHPump, Infusion, Ophthalmic
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 Date2020-11-09
Device Publish Date2020-10-30

Devices Manufactured by SIGHT SCIENCES, INC.

00858027006358 - OMNI PLUS2020-11-09OMNI PLUS Surgical System
00858027006358 - OMNI PLUS2020-11-09 OMNI PLUS Surgical System
10858027006256 - TearCare iLid (TM) Device Packaged Pair - 10 pk2020-03-05 Eyelid heat therapy system applicator 10 pk
10858027006287 - TearCare(TM) SmartLid (TM) (2.2) Packaged Pairs -10 pk 2020-03-05 Eyelid heat therapy system applicator - 10 pk
00858027006228 - TearCare iLid Pair2020-03-05 Eyelid heat therapy system applicator
00858027006334 - OMNI Surgical System (US)2019-11-04 OMNI System for US in a single pack
00858027006013 - VISCO(TM)360 Viscosurgical System2019-10-23 US version of the Visco360
00858027006310 - OMNI Surgical System (US)2019-10-23 Omni System for US in a single pack
00858027006273 - TearCare(TM) (2.2) System Kit2019-09-04 TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and Charger Adapter

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