CALLISTO eye

GUDID 04049539102423

Carl Zeiss Meditec AG

Operating room audiovisual data/device management system
Primary Device ID04049539102423
NIH Device Record Keye15690a6-eaf4-4d42-b1d8-ec4c2de15ef0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCALLISTO eye
Version Model Number3.2.1
Company DUNS342228620
Company NameCarl Zeiss Meditec AG
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS104049539102423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFJSystem, Image Management, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [CALLISTO eye ]

04049539104366CALLISTO eye
040495391024233.2.1
040495390690923.5.1

Trademark Results [CALLISTO eye]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CALLISTO EYE
CALLISTO EYE
77495432 3660054 Live/Registered
Carl Zeiss AG
2008-06-10

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