GUDID 00878953000244

Zeiss Microscope Eye Protection Filter

AMERICAN MEDICAL SYSTEMS

Laser filter, optical
Primary Device ID00878953000244
NIH Device Record Keydfbd9221-97a7-454d-b40c-b334986fd7fa
Commercial Distribution StatusIn Commercial Distribution
Version Model Number0010-0045
Company DUNS796308653
Company NameAMERICAN MEDICAL SYSTEMS
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100878953000244 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-13
Device Publish Date2016-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS

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00878953000015 - AddStat2019-02-13
00878953000046 - EndoStat2019-02-13 0.2mm 12ft
00878953000053 - EndoStat2019-02-13 0.2mm 12ft SL
00878953000060 - EndoStat2019-02-13 0.3mm 12ft
00878953000077 - EndoStat2019-02-13 0.6mm 12ft
00878953000084 - EndoStat2019-02-13 0.6mm 18ft
00878953000091 - EndoStat2019-02-13 0.6mm 12ft

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