CALLISTO eye Panel PC

GUDID 04049539103512

Carl Zeiss Meditec AG

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Primary Device ID04049539103512
NIH Device Record Key330f36af-7125-4f72-b2f3-b9ac6ad5973b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCALLISTO eye Panel PC
Version Model NumberModel II
Company DUNS342228620
Company NameCarl Zeiss Meditec AG
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 Numbertrue
Manufacturing Datetrue
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
GS104049539103512 [Primary]

FDA Product Code

LMDSystem, Digital Image Communications, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-07
Device Publish Date2017-09-22

On-Brand Devices [CALLISTO eye Panel PC]

04049539103512Model II
04049539069214Model III

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