CIRRUS HD-OCT

GUDID 04057748087141

The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imagining of anterior and posterior ocular structures.

Carl Zeiss Meditec, Inc.

Spectral-domain optical coherence tomography system
Primary Device ID04057748087141
NIH Device Record Keydbae982e-d19d-44e1-8b1c-857a398c99f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCIRRUS HD-OCT
Version Model Number6000
Company DUNS362747011
Company NameCarl Zeiss Meditec, 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 Batchfalse
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
GS104057748087141 [Primary]

FDA Product Code

OBOTomography, Optical Coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-11
Device Publish Date2019-11-01

On-Brand Devices [CIRRUS HD-OCT ]

04057748087127The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging de
04057748087097The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging de
04057748087080The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining dev
04057748087141The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining dev

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