FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613042592
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
11-8-3111
Device description
"Infant Lacrimal Dilator, 3.2mm Diameter Round Knurled Handle, Overall Length 3"" (80mm)"
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
00194613042592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613042592001946130425921946130425920194613042592

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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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Primary DI, Brand, Company table
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00757770636631Bausch + LombBausch & Lomb IncorporatedHND2026-02-04
05056785303367Double Ended Y and ICL Shaped ManipulatorBLINK MEDICAL LIMITEDHND2026-02-04
B382S344901080Surgical DirectSurgical Direct, Inc.HND2026-02-04
B382S344932020Surgical DirectSurgical Direct, Inc.HND2026-02-04
B382S344961000Surgical DirectSurgical Direct, Inc.HND2026-02-04
05056785303343Connor WandBLINK MEDICAL LIMITEDHND2026-01-26
00840319758540Hayden MedicalHayden Medical, Inc.HND2025-12-31
00840319758403Hayden MedicalHayden Medical, Inc.HND2025-12-24
00840319758410Hayden MedicalHayden Medical, Inc.HND2025-12-24
00852194002144HAI SpatulaHightech American Industrial Labs IncHND2025-12-16
G223M1129350Femtosecond SpatulaMedetz Surgical Instruments LLCHND2025-12-16
00757770676361Bausch + LombBausch & Lomb IncorporatedHND2025-12-12
B382S34543110T0Surgical DirectSurgical Direct, Inc.HND2025-12-10
B382S9344951010Surgical DirectSurgical Direct, Inc.HND2025-12-10
00757770695522Bausch + LombBausch & Lomb IncorporatedHND2025-11-16
00757770697892Bausch + LombBausch & Lomb IncorporatedHND2025-11-16
00757770688524Bausch + LombBausch & Lomb IncorporatedHND2025-11-14
B382S340861160Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382S344101420Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382S4088010Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382SD9340311000Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382SD9343771110Surgical DirectSurgical Direct, Inc.HND2025-11-11
G346EP55L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-26
G346EP1650Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-23
B382S9340861010Surgical DirectSurgical Direct, Inc.HND2025-09-22
G346EC222SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-18