Khaw 4D Direct View Gonio Diagnostic Lens

GUDID 00630238080309

OCULAR INSTRUMENTS, INC.

Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope Gonioscope
Primary Device ID00630238080309
NIH Device Record Keyf4fc276b-e824-49f9-8630-120c52324513
Commercial Distribution StatusIn Commercial Distribution
Brand NameKhaw 4D Direct View Gonio Diagnostic Lens
Version Model NumberOK4DG
Company DUNS046212387
Company NameOCULAR INSTRUMENTS, 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 Datefalse
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
GS100630238080309 [Primary]
GS100630238080354 [Direct Marking]

FDA Product Code

HKSPrism, Gonioscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238080309]

High-level Disinfectant


[00630238080309]

High-level Disinfectant


[00630238080309]

High-level Disinfectant


[00630238080309]

High-level Disinfectant


[00630238080309]

High-level Disinfectant


[00630238080309]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-19
Device Publish Date2019-06-11

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