FDA.reportPublic FDA data

TearCare(R) Clearance Assistant - Sterile

Primary DI
00858027006266
Brand
TearCare(R) Clearance Assistant - Sterile
Company
Sight Sciences, Inc.
Model
FG 05642
Catalog number
5-104
Device description
Forceps - Sterile
Published
2018-04-23
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNSExpressorOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858027006263PackageGS110In Commercial Distribution
00858027006266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085802700626310858027006263
00858027006266008580270062668580270062660858027006266

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-useA sterile, hand-held manual surgical instrument designed to facilitate grasping, manipulation or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design, with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. 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
00858027006389TearCare(R) Clearance Assistant PLUSFG 069505-1072023-08-22
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
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
00041533986102Bruder CollinsThe Hilsinger Company Parent, LlcHNS2025-10-20
00757770402939Bausch + LombBausch & Lomb IncorporatedHNS2025-08-08
00757770418466Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770418473Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770429158Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770433414Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00194613101411MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-08-01
00194613101428MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-08-01
00194613113315MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-03-21
00757770419944Bausch + LombBausch & Lomb IncorporatedHNS2024-12-30
00757770535545Bausch + LombBausch & Lomb IncorporatedHNS2024-11-20
G2231112380Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNS2023-09-25
00858027006389TearCare(R) Clearance Assistant PLUSSight Sciences, Inc.HNS2023-08-22
00190660034948Ambler SurgicalAMBLER SURGICAL CORP.HNS2021-01-07
00190660034955Ambler SurgicalAMBLER SURGICAL CORP.HNS2021-01-07
00190660034962Ambler SurgicalAMBLER SURGICAL CORP.HNS2021-01-07
B5821051631140N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821058710N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821058800N/AGEORGE TIEMANN & CO.HNS2020-09-24
B582105901H0N/AGEORGE TIEMANN & CO.HNS2020-09-24
B582105901K0N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059040N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059050N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059060N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059100N/AGEORGE TIEMANN & CO.HNS2020-09-24