132D Indirect Vitrectomy Lens

GUDID 00630238074001

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, reusable
Primary Device ID00630238074001
NIH Device Record Key9ad67c9f-3e6e-46b8-9115-b1244802f202
Commercial Distribution StatusIn Commercial Distribution
Brand Name132D Indirect Vitrectomy Lens
Version Model NumberOIV-132
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
GS100630238074001 [Primary]

FDA Product Code

HJLLens, Condensing, 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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