FDA.reportPublic FDA data

TearCare(R) Clearance Assistant PLUS

Primary DI
00858027006389
Brand
TearCare(R) Clearance Assistant PLUS
Company
Sight Sciences, Inc.
Model
FG 06950
Catalog number
5-107
Device description
TearCare Clearance Assistant PLUS
Published
2023-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HNSExpressor
HNZCurette, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNSExpressorOphthalmic1
HNZCurette, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858027006386PackageGS110In Commercial Distribution
00858027006389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085802700638610858027006386
00858027006389008580270063898580270063890858027006389

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic curette, single-useA hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962750381
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858027006372OMNI(R) Surgical System (US)FG 067211-1022020-06-01
00858027006549TearCare MGX System - TearCare MGX Technology KitFG 087895-1182025-04-30
00858027006297TearCare MGX System - TearCare MGX SmartLidsFG 087855-1092025-04-29
00858027006594OMNI Edge Surgical System1-1122025-03-06
00858027006280TearCare SmartLid FG 061135-1052019-08-27
00858027006358OMNI PLUS1-1042020-10-30
00858027006433OMNI Surgical SystemFG 077581-1062023-10-17
00858027006266TearCare(R) Clearance Assistant - SterileFG 056425-1042018-04-23
00858027006525OMNI Surgical SystemFG 074411-1082022-08-22
00858027006501Sion Surgical InstrumentFG 082551-1072022-08-01
00858027006457TearCare System - TearCare SmartHub KitFG 073925-1162022-03-03
00858027006495TearCare System - TearCare SmartLidsFG 079385-1172022-03-03
00858027006273TearCare(TM) (2.2) System KitFG 060415-1002019-08-27
10858027006256TearCare iLid (TM) Device Packaged Pair - 10 pkFG 056205-1012018-03-16
00858027006334OMNI Surgical System (US)FG 057571-1022019-10-25
00858027006013VISCO(TM)360 Viscosurgical SystemFG 039162016-09-22
00858027006112TRAB(TM)360 Trabeculotomy SystemFG 037062016-11-23
00858027006211TearCare SystemFG 050312017-02-01
00858027006228TearCare iLid PairFG 051182017-02-01
00858027006242TearCare(TM) System KitFG 055095-1002018-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770505708Bausch + LombBausch & Lomb IncorporatedHNZ2026-04-30
00041533986119BruderThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986201Bruder LivengoodThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986300Bruder LivengoodThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986126Bruder The Hilsinger Company Parent, LlcHNS2025-11-21
00041533986133BruderThe Hilsinger Company Parent, LlcHNS2025-11-21
04058935013288Terry Scraper Non Irr DSEKBausch & Lomb GmbHHNZ2025-10-26
00041533986102Bruder CollinsThe Hilsinger Company Parent, LlcHNS2025-10-20
00190776410780MillenniumAvalign Technologies, Inc.HNZ2025-09-12
00757770636242Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-13
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNZ2025-08-11
00757770402939Bausch + LombBausch & Lomb IncorporatedHNS2025-08-08
00757770407583Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770415199Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770415533Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770419029Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770419401Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770433636Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770436385Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770418466Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770418473Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770429158Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770433414Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00194613005160MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613087142MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613100377MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613101411MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-08-01
00194613101428MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-08-01
00194613101558MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613101572MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01