Disposable Vitrectomy Lens Mag., 10 PK

GUDID 00630238090001

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, single-use
Primary Device ID00630238090001
NIH Device Record Key705ff9f6-55a8-40d6-a077-5f9b5c807d9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Vitrectomy Lens Mag., 10 PK
Version Model NumberODVM
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
GS100630238090001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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