FDA.reportPublic FDA data

Single Use 3-Mirror Gonio

Primary DI
10811608019120
Brand
Single Use 3-Mirror Gonio
Company
VOLK OPTICAL INC.
Model
V3MIRD
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
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
10811608019120PackageGS110In Commercial Distribution
20811608019127PackageGS1100In Commercial Distribution
30811608019124PackageGS1400In Commercial Distribution
00811608019123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081160801912010811608019120
2081160801912720811608019127
3081160801912430811608019124
00811608019123008116080191238116080191230811608019123

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

Contacts#

Phone, Email table
PhoneEmail
440-942-6161snigdha.katragadda@volk.com

Regulatory Flags#

DUNS number
071125835
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811608019895GonioPro Surgical Lens + Handle (VSGLHACS)VSGLHACS2026-02-04
10811608019908Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD)VSGSAD2026-02-04
10811608019915Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)VSGSBD2026-02-04
10811608019922Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD)VSGLSAD2026-02-04
10811608019939Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)VSGLSBD2026-02-04
10811608019946Single Use GonioPro Surgical Lens + Handle (VSGLHD)VSGLHD2026-02-04
00811608019802Rapid SLTVLUMSLT2025-08-07
0081160801981920D Limited Edition #2V20LC-LE22025-08-01
0081160801982628D Limited Edition #2V28LC-LE22025-08-01
00811608019833Pan Retinal 2.2 Limited Edition #2VPRC-LE22025-08-01
0081160801984078D Limited Edition #2V78C-LE22025-08-01
0081160801985790D Limited Edition #2V90C-LE22025-08-01
00811608019864Super 66® Limited Edition #2VS66-LE22025-08-01
00811608019871SuperField® Limited Edition #2VSFNC-LE22025-08-01
00811608019888Digital Wide Field® Limited Edition #2VDGTLWF-LE22025-08-01
00811608019376Mounting Kit, Topcon OMS-800121622025-06-30
00811608019796Mounting Kit, MediWorks SM621126552025-06-30
00811608019765Mounting Kit, Alcon Revalia126402025-03-26
00811608019772Mounting Kit, Takagi OM-9126452025-03-26
00811608019789Mounting Kit, Takagi OM-19126502025-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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
008116080134593 Mirror No FlangeVOLK OPTICAL INC.HKS2020-09-25
008116080134663 Mirror ANF+VOLK OPTICAL INC.HKS2020-09-25
00811608013497Uncoated 3 Mirror NFVOLK OPTICAL INC.HKS2020-09-25
00811608013503Uncoated 3 Mirror ANF+VOLK OPTICAL INC.HKS2020-09-25
00811608013510G-1 Trabeculum FlangeVOLK OPTICAL INC.HKS2020-09-25
00811608013527G-1 Trabeculum NFVOLK OPTICAL INC.HKS2020-09-25
00811608013534G-2 Trabeculum FlangeVOLK OPTICAL INC.HKS2020-09-25
00811608013541G-2 Trabeculum NFVOLK OPTICAL INC.HKS2020-09-25