FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613050979
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
15-3628AS
Device description
"Nagahara Phaco Chopper, For Use In LH, Angled 45 Degrees, Flat Interior Cutting Edge, 10mm Bend To Tip, 1.5mm 60 Degrees Long Cutting Edge, Round Knurled Handle, Overall Length 4-1/2"" (114mm)"
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
HNDSpatula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613050979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613050979001946130509791946130509790194613050979

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.

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

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