FDA.reportPublic FDA data

Posner Diagnostic & Surgical Gonioprism w/Round Handle (Red)

Primary DI
00630238085762
Brand
Posner Diagnostic & Surgical Gonioprism w/Round Handle (Red)
Company
OCULAR INSTRUMENTS, INC.
Model
OPDSG/R
Published
2019-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00630238086011Direct MarkingGS10
00630238085762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630238086011006302380860116302380860110630238086011
00630238085762006302380857626302380857620630238085762

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
High-level Disinfectant

Regulatory Flags#

DUNS number
046212387
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
00630238009973Landers Lens ForcepsOLV-FCP2019-06-12
00630238056656Handle For Vitrectomy LensesOLIV-H2019-06-12
00630238084741MaxAC® Lens StandOI-LSA2019-06-11
00630238095235MaxField® 100D Slit Lamp Indirect Lens (Green)OI-100M/GN2019-06-10
00630238081795MaxLight® Standard 90D Slit Lamp Indirect Lens (Green)OI-STD/GN2019-06-11
00630238049023Ultra View Small Pupil Slit Lamp Binocular Indirect LensOI-SP2019-06-11
00630238077422MaxAC® 20D Binocular Indirect LensOI-20A2019-06-11
00630238077491MaxAC® 28D Binocular Indirect LensOI-28A2019-06-11
00630238081658MaxField® Standard 90D Slit Lamp Indirect Lens (Red)OI-STDM/R2019-06-11
00630238082082MaxLight® Standard 90D Slit Lamp Indirect Lens (Red)OI-STD/R2019-06-11
00630238082983MaxLight® High Mag 78D Slit Lamp Indirect Lens (Purple)OI-HM/P2019-06-11
00630238083058MaxLight® High Mag 78D Slit Lamp Indirect Lens (Gold)OI-HM/GD2019-06-11
00630238083331MaxField® Standard 90D Slit Lamp Indirect Lens w/Large Ring (Purple)OI-STDM-LR/P2019-06-11
00630238085113MaxField® High Mag 78 Slit Lamp Indirect Lens (Purple)OI-HM-78M/P2019-06-11
00630238085144MaxField® High Mag 78 Slit Lamp Indirect Lens (Red)OI-HM-78M/R2019-06-11
00630238092647MaxField® 22D Binocular Indirect Lens (Blue)OI-22M/B2019-06-11
00630238096959Saxena Retinal Grid 520OI-SRG5202019-06-11
00630238099073MaxLight® 18D Binocular Indirect Lens (Green)OI-18/GN2019-06-11
00630238099325MaxField® 18D Binocular Indirect Lens (Green)OI-18M/GN2019-06-11
00630238099332MaxField® 18D Binocular Indirect Lens (Purple)OI-18M/P2019-06-11

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
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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
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