FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613087500
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
OKES-12
Device description
Koeppe Diagnostic Gonio Lens, Extra Small, 12mm
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
HKSPrism, gonioscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKSPrism, GonioscopicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613087500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613087500001946130875001946130875000194613087500

GMDN Terms#

Term, Definition table
TermDefinition
GonioscopeA device intended to be used to examine the angle of the anterior chamber of the eye and for demonstrating ocular motility and rotation.

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
00811608019994Single Use GonioPro Surgical Lens Sample Box (VSGSAMPLEBOX)VOLK OPTICAL INC.HKS2026-04-07
00811608019901Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD)VOLK OPTICAL INC.HKS2026-02-04
00811608019918Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)VOLK OPTICAL INC.HKS2026-02-04
00811608019925Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD)VOLK OPTICAL INC.HKS2026-02-04
00811608019932Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)VOLK OPTICAL INC.HKS2026-02-04
00811608019949Single Use GonioPro Surgical Lens + Handle (VSGLHD)VOLK OPTICAL INC.HKS2026-02-04
00811608019895GonioPro Surgical Lens + Handle (VSGLHACS)VOLK OPTICAL INC.HKS2026-02-04
10811608019908Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD)VOLK OPTICAL INC.HKS2026-02-04
10811608019915Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)VOLK OPTICAL INC.HKS2026-02-04
10811608019922Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD)VOLK OPTICAL INC.HKS2026-02-04
10811608019939Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)VOLK OPTICAL INC.HKS2026-02-04
10811608019946Single Use GonioPro Surgical Lens + Handle (VSGLHD)VOLK OPTICAL INC.HKS2026-02-04
10841668146580GlaukosKATENA PRODUCTS, INC.HKS2026-01-15
00811608019802Rapid SLTVOLK OPTICAL INC.HKS2025-08-07
00194613121846MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-08-01
00194613121853MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-08-01
00194613121952MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-08-01
00194613121976MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-08-01
00194613122621MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-08-01
00194613122645MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-08-01
00194613122652MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-08-01
00194613123246MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-08-01
04049584034212GONIO ready® CLOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHKS2025-05-09
04049584034229GONIO ready® CLOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHKS2025-05-09
00194613121808MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-03-21
00194613122638MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-03-21
04049584034465GONIO ready® 200 for f=200OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHKS2023-03-27
04049584034472GONIO ready® 175 for f=175OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHKS2023-03-27
04049584033048GONIO ready® 200 for f=200OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHKS2023-03-27
04049584034489GONIO ready® 175 for f=175OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHKS2023-03-27