FDA.reportPublic FDA data

GONIO ready® 175 for f=175

Primary DI
04049584034472
Brand
GONIO ready® 175 for f=175
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
10011228
Device description
GONIO ready® 175 for f=175
Published
2023-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
04049584034489PackageGS16In Commercial Distribution
04049584034472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584034489040495840344894049584034489
04049584034472040495840344724049584034472

GMDN Terms#

Term, Definition table
TermDefinition
Microscope objectiveA lens or lens group that forms the part of the optical system of a microscope closest to the object. It is used to magnify the viewed image. The objective may be supplied singularly, in pairs, or in sets of increasing magnification.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584034953Pentacam Cornea OCT100190012026-03-31
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14

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
00194613087500MSI Precision Specialty InstrumentsMed Saver, Inc.HKS2025-03-21
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
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