FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613042813
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
28274M
Device description
"Lerner Croy Capsulorhexis Utrata Forceps, 11.5mm Vaulted Shanks, Fine Angled Cystotome Tips, Slight Serrations On The Inside, Ergonomic Round Masket Handle, Overall Length 4-1/3"" (110mm)"
Published
2024-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613042813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613042813001946130428131946130428130194613042813

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
00194613046149MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2024-08-15
00840516141183Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2024-08-15
08052276012432Irrigating Cystotome Ang.45° 27Gx16mm AKTIVE SRLHNY2023-12-19
08052276012937Irrigating Cystotome Formed 27G x 16mmAKTIVE SRLHNY2023-12-19
08052276012968Irrigating Cystotome Ang.45° 25G x16 mm AKTIVE SRLHNY2023-12-19
00840516105345Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-10-10
00840516116600Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116617Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116624Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116631Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116648Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116655Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116662Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116679Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116686Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116693Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116709Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116716Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116754Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116761Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116778Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116785Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116792Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116808Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116815Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116822Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116839Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116846Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116853Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116860Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28