Karickhoff 25mm Off-Axis Vitreous Laser Lens

GUDID 00630238088435

OCULAR INSTRUMENTS, INC.

Laser lens, ophthalmic, surgical
Primary Device ID00630238088435
NIH Device Record Keybb6eea61-aafa-48d8-99bf-026257f77e4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameKarickhoff 25mm Off-Axis Vitreous Laser Lens
Version Model NumberOJKPY-25
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100630238088435 [Primary]
GS100630238088459 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


[00630238088435]

High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-09

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