Four Mirror Gonioprism 2mm O.D.

GUDID 00630238077040

OCULAR INSTRUMENTS, INC.

Gonioscope
Primary Device ID00630238077040
NIH Device Record Key331c197c-7d2c-43db-aeb4-8bbae2a7558c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFour Mirror Gonioprism 2mm O.D.
Version Model NumberOGP2
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
GS100630238077040 [Primary]

FDA Product Code

HKSPrism, Gonioscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238077040]

High-level Disinfectant


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.