Disposable Vitrectomy Lense Wide, 10 PK

GUDID 00630238090025

OCULAR INSTRUMENTS, INC.

Vitrectomy contact lens, single-use
Primary Device ID00630238090025
NIH Device Record Key92758726-7b21-4fcd-a49b-2d4b47a22bf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Vitrectomy Lense Wide, 10 PK
Version Model NumberODVW
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
GS100630238090025 [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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.