Disposable Flat Vitrectomy

GUDID 00630238075213

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, single-use Vitrectomy contact lens, single-use
Primary Device ID00630238075213
NIH Device Record Keyf0260964-f1c3-45fc-9db1-ff9e66cbdd59
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Flat Vitrectomy
Version Model NumberODVF 12179
Company DUNS046212387
Company NameOCULAR INSTRUMENTS, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100063023812179 [Unit of Use]
GS100630238075213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-09

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