WF/HM NA Vitrectomy Lens Set

GUDID 00630238066693

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, reusable
Primary Device ID00630238066693
NIH Device Record Keya17f4d2c-8421-4a08-8bf1-a5170458ef8a
Commercial Distribution Discontinuation2018-10-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameWF/HM NA Vitrectomy Lens Set
Version Model NumberOLIV-WHNA
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
GS100630238066693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238066693]

Peracetic Acid;Ozone;Hydrogen Peroxide;Ethylene Oxide


[00630238066693]

Peracetic Acid;Ozone;Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-17
Device Publish Date2016-12-12

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