Ritch Trabeculoplasty Laser Lens 712

GUDID 00630238007122

OCULAR INSTRUMENTS, INC.

Laser lens, ophthalmic, surgical
Primary Device ID00630238007122
NIH Device Record Keyc34bda3f-bd2d-4385-bb47-ea4cd3142f46
Commercial Distribution StatusIn Commercial Distribution
Brand NameRitch Trabeculoplasty Laser Lens
Version Model NumberORTA
Catalog Number712
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
GS100630238007122 [Primary]
GS100630238021333 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKSPrism, Gonioscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


[00630238007122]

High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-19
Device Publish Date2019-06-12

On-Brand Devices [Ritch Trabeculoplasty Laser Lens]

00063023800712ORTA
00630238007122ORTA

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