FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613086435
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
581049
Device description
Surgical Glide (Fichman), 30mm Long; 6mm Thick; Phaco Glide 10mm Long x 2.6mm Wide, Tapered To 1.75mm, IOL Glide Portion; 20mm Long x 5mm Wide, 2.5mm Radius, Box Of 50
Published
2025-08-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYBLENS, GUIDE, INTRAOCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYBLens, Guide, IntraocularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613086435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613086435001946130864351946130864350194613086435

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, single-useA hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)935-8181sales@msiprecision.com

Regulatory Flags#

DUNS number
556623486
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
00194613017279MSI Precision Specialty InstrumentsE53772025-08-01
00194613017286MSI Precision Specialty InstrumentsE53782025-08-01
00194613018993MSI Precision Specialty InstrumentsM134002025-08-01
00194613044572MSI Precision Specialty InstrumentsF94982025-08-01
00194613089696MSI Precision Specialty InstrumentsF94952025-08-01
00194613109684MSI Precision Specialty InstrumentsE53702025-08-01
00194613110772MSI Precision Specialty InstrumentsE53762025-08-01
00194613003845MSI Precision Specialty Instruments5-14452024-08-15
00194613044800MSI Precision Specialty Instruments17-13502024-08-15
00194613045173MSI Precision Specialty Instruments17-13302024-08-15
00194613045685MSI Precision Specialty Instruments2380182024-08-15
00194613046354MSI Precision Specialty Instruments17-13122024-08-15
00194613055332MSI Precision Specialty Instruments17-13102024-08-15
00194613018382MSI Precision Specialty Instruments52-20632025-08-01
00194613018504MSI Precision Specialty Instruments52-22612025-08-01
00194613018771MSI Precision Specialty Instruments51-23012025-08-01
00194613018788MSI Precision Specialty Instruments51-25012025-08-01
00194613018856MSI Precision Specialty Instruments51-19012025-08-01
00194613020873MSI Precision Specialty Instruments51-20012025-08-01
00194613000004MSI Precision Specialty InstrumentsCA10002025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055214935VISCOJECT 1.8 Injector SetMedicel AGKYB2026-04-28
07630055213853VISCOJECT 2.2 Injector SetMedicel AGKYB2026-04-24
00194613123147MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-03-21
00840311344796MicroStaarSTAAR SURGICAL COMPANYKYB2023-06-15
05055313817222Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313818922Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313820901Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313821632Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
05055313822295Duckworth & KentDUCKWORTH AND KENT LIMITEDKYB2022-08-31
00757770473946Bausch + LombBausch & Lomb IncorporatedKYB2022-02-25
00380659777738MONARCH® IIIAlcon Laboratories, Inc.KYB2020-08-19
00380659777578MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
00380659777585MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
00380659777639MONARCH® IIIAlcon Laboratories, Inc.KYB2020-05-20
10380659777575MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
10380659777582MONARCH® IIAlcon Laboratories, Inc.KYB2020-05-20
10380659777636MONARCH® IIIAlcon Laboratories, Inc.KYB2020-05-20
00813465011135IOL Manipulator - LesterHURRICANE MEDICAL INCKYB2020-05-08
00813465011142IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
00813465011166IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
00813465011173Nucleus Chopper - P. KochHURRICANE MEDICAL INCKYB2020-05-08
00813465011180Nucleus Chopper - BeckingsaleHURRICANE MEDICAL INCKYB2020-05-08
10813465011132IOL Manipulator - LesterHURRICANE MEDICAL INCKYB2020-05-08
10813465011149IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
10813465011163IOL Manipulator - SinskeyHURRICANE MEDICAL INCKYB2020-05-08
10813465011170Nucleus Chopper - P. KochHURRICANE MEDICAL INCKYB2020-05-08
10813465011187Nucleus Chopper - BeckingsaleHURRICANE MEDICAL INCKYB2020-05-08
00813465012071Surgical GlideHURRICANE MEDICAL INCKYB2020-05-05
00813465012101IOL Glide - SheetsHURRICANE MEDICAL INCKYB2020-05-05
10813465012078Surgical GlideHURRICANE MEDICAL INCKYB2020-05-05