FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613104665
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
5003AF
Device description
"Irrigating Cystotome, 25ga, Formed, 5/8"" (16mm)"
Published
2025-03-21
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
00194613104665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613104665001946131046651946131046650194613104665

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
00841668145968BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145982BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145999BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146002BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146019BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146071BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146095BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146132BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146149BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146170BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146194BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146200BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146231BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146248BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00757770416783Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770429943Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770433896Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00194613002251MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002275MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002305MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002329MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002336MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002343MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002459MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613052317MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103576MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103620MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103859MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613104245MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613104672MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01