Woldoff High Mag Vitrectomy Lens NA

GUDID 00630238065627

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, reusable
Primary Device ID00630238065627
NIH Device Record Key33a08a83-2c8c-4e59-aa8b-0daf46c21ee4
Commercial Distribution StatusIn Commercial Distribution
Brand NameWoldoff High Mag Vitrectomy Lens NA
Version Model NumberOWIV-HMNA
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
GS100630238065627 [Primary]
GS100630238065689 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238065627]

Ozone;Ethylene Oxide;Hydrogen Peroxide;Peracetic Acid


[00630238065627]

Ozone;Ethylene Oxide;Hydrogen Peroxide;Peracetic Acid


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-24
Device Publish Date2016-12-09

Devices Manufactured by OCULAR INSTRUMENTS, INC.

00630238081795 - MaxLight® Standard 90D Slit Lamp Indirect Lens (Green)2021-03-17
00630238007122 - Ritch Trabeculoplasty Laser Lens2020-02-19
00630238122245 - 13063 RxSight 0.766x Mag Contact Lens2019-09-19
00630238084741 - MaxAC® Lens Stand2019-09-10
00063023800712 - Ritch Trabeculoplasty Laser Lens2019-06-20
00630238006972 - Koeppe Extra Small Diagnostic Lens 12mm O.D. 2019-06-20
00630238007092 - Single Mirror Kaufman Laser Lens2019-06-20
00630238008075 - Koeppe Large Diagnostic Lens 19mm O.D.2019-06-20

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.