GUDID 00878953000466

Sinus-90 Suction Microstat Left Hand

AMERICAN MEDICAL SYSTEMS

Laser beam delivery unit holder
Primary Device ID00878953000466
NIH Device Record Keyfc39e03b-e028-441e-8b76-53848505d504
Commercial Distribution StatusIn Commercial Distribution
Version Model Number0010-0998
Company DUNS796308653
Company NameAMERICAN MEDICAL SYSTEMS
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 Batchtrue
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 Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953000466 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00878953000466]

Moist Heat or Steam Sterilization


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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.