GonioPro Surgical Lens + Handle (VSGLHACS)

GUDID 00811608019895

VOLK OPTICAL INC.

Gonioscope
Primary Device ID00811608019895
NIH Device Record Key2276edbf-bd9c-45cd-9937-d8160f971287
Commercial Distribution StatusIn Commercial Distribution
Brand NameGonioPro Surgical Lens + Handle (VSGLHACS)
Version Model NumberVSGLHACS
Company DUNS071125835
Company NameVOLK OPTICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811608019895 [Primary]

FDA Product Code

HKSPrism, Gonioscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


[00811608019895]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-12
Device Publish Date2026-02-04

Devices Manufactured by VOLK OPTICAL INC.

00811608019895 - GonioPro Surgical Lens + Handle (VSGLHACS)2026-02-12
00811608019895 - GonioPro Surgical Lens + Handle (VSGLHACS)2026-02-12
10811608019908 - Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD)2026-02-12
10811608019915 - Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)2026-02-12
10811608019922 - Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD)2026-02-12
10811608019939 - Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)2026-02-12
10811608019946 - Single Use GonioPro Surgical Lens + Handle (VSGLHD)2026-02-12
00811608019802 - Rapid SLT2025-08-15
00811608019819 - 20D Limited Edition #22025-08-11

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