IRIDEX MicroPulse® Laser Trabeculoplasty Lens

GUDID 00630238115643

OCULAR INSTRUMENTS, INC.

Laser lens, ophthalmic, surgical
Primary Device ID00630238115643
NIH Device Record Key233714ee-34df-4905-b801-15fe22f3724c
Commercial Distribution StatusIn Commercial Distribution
Brand NameIRIDEX MicroPulse® Laser Trabeculoplasty Lens
Version Model NumberOIMLT
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
GS100630238115643 [Primary]
GS100630238115698 [Direct Marking]

FDA Product Code

HKSPrism, Gonioscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

High-level Disinfectant


[00630238115643]

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

Devices Manufactured by OCULAR INSTRUMENTS, INC.

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00630238122245 - 13063 RxSight 0.766x Mag Contact Lens2019-09-19
00630238084741 - MaxAC® Lens Stand2019-09-10
00063023800712 - Ritch Trabeculoplasty Laser Lens2019-06-20
00630238006972 - Koeppe Extra Small Diagnostic Lens 12mm O.D. 2019-06-20
00630238007092 - Single Mirror Kaufman Laser Lens2019-06-20
00630238008075 - Koeppe Large Diagnostic Lens 19mm O.D.2019-06-20

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