Saxena Retinal Grid 428

GUDID 00630238100588

OCULAR INSTRUMENTS, INC.

Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens
Primary Device ID00630238100588
NIH Device Record Keyb76e0b96-cd01-4332-92a7-3d7ae86ede32
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaxena Retinal Grid 428
Version Model NumberOI-SRG428
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
GS100630238100588 [Primary]
GS100630238100625 [Direct Marking]

FDA Product Code

HJLLens, Condensing, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

High-level Disinfectant


[00630238100588]

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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