S7 / OPMI PROergo

GUDID 04049539104137

Carl Zeiss Meditec AG

General-purpose surgical microscope
Primary Device ID04049539104137
NIH Device Record Key35d419bf-e73b-40e4-a4a2-2c61c53db2a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameS7 / OPMI PROergo
Version Model Number000000-1254-579
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
GS104049539104137 [Primary]

FDA Product Code

FSOMicroscope, Surgical, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-04
Device Publish Date2023-04-26

On-Brand Devices [S7 / OPMI PROergo]

04049539104144000000-1254-580
04049539104137000000-1254-579
04049539104120000000-1193-109
04049539104113000000-1226-405
04049539104106000000-1103-022
04049539104090000000-1087-851

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