Latina 1x Indexing PSLT Gonio Laser Lens

GUDID 00630238118392

OCULAR INSTRUMENTS, INC.

Gonioscope
Primary Device ID00630238118392
NIH Device Record Key26d42f0c-e529-4ca7-a700-0721b51d193d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLatina 1x Indexing PSLT Gonio Laser Lens
Version Model NumberOL1PLTF
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
GS100630238118392 [Primary]
GS100630238118453 [Direct Marking]

FDA Product Code

HKSPrism, Gonioscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


[00630238118392]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-18
Device Publish Date2019-06-10

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.