FDA.reportPublic FDA data

TearCare(R) Clearance Assistant - Sterile - 10 pk

Primary DI
10858027006263
Brand
TearCare(R) Clearance Assistant - Sterile - 10 pk
Company
SIGHT SCIENCES, INC.
Model
FG 05642
Catalog number
5-104
Device description
Forceps - Sterile - 10 pack
Published
2018-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858027006263PrimaryGS10
00858027006266Unit of UseGS10

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
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995317973V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318024V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318246V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318253V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318284V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318307V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318338V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318345V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318451V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318468V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318475V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318482V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318499V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318598V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318673V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318680V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318697V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318703V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318741V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318772V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318833V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318857V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318932V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318949V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995317980V. MuellerSteris CorporationHNR2026-09-24
00724995318321V. MuellerSteris CorporationHNR2026-09-24
00724995318413V. MuellerSteris CorporationHNR2026-09-24
00724995318420V. MuellerSteris CorporationHNR2026-09-24
00724995318437V. MuellerSteris CorporationHNR2026-09-24
00724995318444V. MuellerSteris CorporationHNR2026-09-24