Two Mirror Gonio Laser Lens

GUDID 00630238053440

OCULAR INSTRUMENTS, INC.

Gonioscope
Primary Device ID00630238053440
NIH Device Record Key37f0c1b1-6044-4353-b1c0-489bfce1648b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwo Mirror Gonio Laser Lens
Version Model NumberO2MA
Company DUNS046212387
Company NameOCULAR INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100630238053440 [Primary]
GS100630238053655 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKSPrism, Gonioscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

High-level Disinfectant


[00630238053440]

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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