TearCare iLid (TM) Device Packaged Pair - 10 pk 5-101

GUDID 10858027006256

Eyelid heat therapy system applicator 10 pk

SIGHT SCIENCES, INC.

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Primary Device ID10858027006256
NIH Device Record Keyef425ea3-71f7-4eb0-8334-4064c021fca5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTearCare iLid (TM) Device Packaged Pair - 10 pk
Version Model NumberFG 05620
Catalog Number5-101
Company DUNS962750381
Company NameSIGHT SCIENCES, INC.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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
GS100858027006259 [Unit of Use]
GS110858027006256 [Primary]

FDA Product Code

IRTPad, Heating, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2018-03-16

Devices Manufactured by SIGHT SCIENCES, INC.

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
00858027006495 - TearCare System - TearCare SmartLids2022-03-11 Eyelid heat therapy system applicator

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