VISCO(TM)360 Viscosurgical System

GUDID 00858027006013

US version of the Visco360

SIGHT SCIENCES, INC.

Ophthalmic needle, single-use
Primary Device ID00858027006013
NIH Device Record Keya4b04173-8333-47f4-a45a-9b6a69309cc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVISCO(TM)360 Viscosurgical System
Version Model NumberFG 03916
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
GS100858027006013 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2016-09-22

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00858027006457 - TearCare System - TearCare SmartHub Kit2022-03-11 TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
00858027006495 - TearCare System - TearCare SmartLids2022-03-11 Eyelid heat therapy system applicator

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