PLEX Elite

GUDID 04057748087110

The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device int

Carl Zeiss Meditec, Inc.

Retinal optical coherence tomography system
Primary Device ID04057748087110
NIH Device Record Key2353f26a-f8ce-4767-a1d5-5fef23030d0e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLEX Elite
Version Model Number9000
Company DUNS362747011
Company NameCarl Zeiss Meditec, 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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104057748087110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBOTomography, Optical Coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-26
Device Publish Date2017-04-14

Devices Manufactured by Carl Zeiss Meditec, Inc.

04057748087141 - CIRRUS HD-OCT 2019-11-11 The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing
04057748096044 - CLARUS2019-07-09 The CLARUS 700 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human e
04057748085284 - Humphrey Field Analyzer 3 (HFA3) 2019-04-01 The Humphrey Field Analyzer is an automated perimeter intended to identify visual field defects for the purposes of screening, m
04057748096037 - CLARUS2019-03-08 The CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human e
04057748096051 - CLARUS2019-03-08 The CLARUS is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye.
04057748087080 - CIRRUS HD-OCT2018-10-26 The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing
04057748087097 - CIRRUS HD-OCT2018-10-26 The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewin
04057748087110 - PLEX Elite2018-10-26The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device int
04057748087110 - PLEX Elite2018-10-26 The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicros
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.