CIRRUS HD-OCT

GUDID 04057748087097

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional

Carl Zeiss Meditec, Inc.

Spectral-domain optical coherence tomography system
Primary Device ID04057748087097
NIH Device Record Key8ef6aead-9554-453b-aa47-0f69ea4d08f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCIRRUS HD-OCT
Version Model Number500
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104057748087097 [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 Date2016-08-25

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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