GUDID 00878953000282

Microscope Eye Protection Filter, Wild

AMERICAN MEDICAL SYSTEMS

Laser filter, optical Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter
Primary Device ID00878953000282
NIH Device Record Keyd115c0da-19c7-4198-a8e9-8e0fd2a8b176
Commercial Distribution StatusIn Commercial Distribution
Version Model Number0010-6212
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 Identifiers

Device Issuing AgencyDevice ID
GS100878953000282 [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

00878953004822 - SureFlex 2002019-04-25 200 Lithotripsy Fiber
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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