BLUE 400 S

GUDID 04049539070593

accessory to surgical microscopes

Carl Zeiss Meditec AG

Neurosurgical microscope
Primary Device ID04049539070593
NIH Device Record Keyf6e51c53-99b5-4d36-af9e-d1f42a908eb2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBLUE 400 S
Version Model Number7059
Company DUNS342228620
Company NameCarl Zeiss Meditec AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
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
GS104049539070593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFXDiagnostic Neurosurgical Microscope Filter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-15
Device Publish Date2024-10-07

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