Mainster Wide Filed EX

GUDID 00630238123310

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, reusable
Primary Device ID00630238123310
NIH Device Record Key75877496-36fb-49a4-a6d2-756edf420c5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMainster Wide Filed EX
Version Model NumberOMRA-WFEX
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
GS100630238123020 [Primary]
GS100630238123310 [Direct Marking]

FDA Product Code

HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238123310]

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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