FDA.reportPublic FDA data

Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)

Primary DI
10811608019939
Brand
Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)
Company
VOLK OPTICAL INC.
Model
VSGLSBD
Published
2026-02-04
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

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
10811608019939PackageGS110In Commercial Distribution
20811608019936PackageGS1100In Commercial Distribution
30811608019933PackageGS1800In Commercial Distribution
00811608019932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081160801993910811608019939
2081160801993620811608019936
3081160801993330811608019933
00811608019932008116080199328116080199320811608019932

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

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
00811608019970Mounting Kit, for Kaps SOM62121722026-04-27
00811608019987ROLS Adapter Kit, for Kaps122692026-04-27
00811608019994Single Use GonioPro Surgical Lens Sample Box (VSGSAMPLEBOX)VSGSAMPLEBOX2026-04-07
00811608012872SuperMacula VIT (VSMACVIT)VSMACVIT2016-09-29
00811608012889Central Retinal Vit (VCRLVIT)VCRLVIT2016-09-29
00811608012896Mini Quad VIT (VMQVIT)VMQVIT2016-09-29
00811608012902Dynaview 156 VIT (VDVVIT)VDVVIT2016-09-29
00811608012919Mini Quad XL VIT (VMQXLVIT)VMQXLVIT2016-09-29
00811608012971Central Retinal SSV (VCRLVITSSV)VCRLVITSSV2016-09-28
00811608012988Mini Quad SSV (VMQVITSSV)VMQVITSSV2016-09-28
00811608012995Mini Quad XL VIT SSV (VMQXLVITSSV)VMQXLVITSSV2016-09-29
00811608013053HRX Vit (VHRXVIT)VHRXVIT2016-09-29
00811608013060HRX SSV Vit (VHRXVITSSV)VHRXVITSSV2016-09-28
00811608013305HR Direct 1X Vit (VHRD1XACS)VHRD1XACS2016-09-29
00811608013312HR Direct 1X NSR Vit (VHRD1XNSRACS)VHRD1XNSRACS2016-09-29
00811608013336HR Direct Bi-Concave (VHRDBCACS)VHRDBCACS2016-09-29
00811608013343HR Direct HighMag Vit (VHRDHMACS)VHRDHMACS2016-09-29
00811608013350HR Direct HM NSR Vit (VHRDHMNSRACS)VHRDHMNSRACS2016-09-29
00811608013183Flat SSV ACS (VFLATSSVACS)VFLATSSVACS2016-09-29
0081160801319015 Prism SSV ACS (VPRISMSSVACS)VPRISMSSVACS2016-09-29

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
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
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